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INTRODUCTION: A three-pronged approach to acne treatment combining an antibiotic, antimicrobial, and retinoid may be more efficacious than single/double treatments while potentially reducing antibiotic resistance. This study evaluated the efficacy and safety of the first fixed-dose, triple-combination topical acne product, clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) using pooled phase 3 data. METHODS: In two identical phase 3 (N = 183; N = 180), double-blind, 12-week studies, participants aged ≥ 9 years with moderate-to-severe acne were randomized 2:1 to receive once-daily CAB or vehicle gel. Endpoints included ≥ 2-grade reduction from baseline in Evaluators Global Severity Score and clear/almost clear skin (treatment success) and least-squares mean percent change from baseline in acne lesion counts. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated. RESULTS: At week 12, 50.0% of participants achieved treatment success with CAB versus 22.6% with vehicle gel (P  70% reductions in inflammatory and noninflammatory lesions at week 12 (77.9% and 73.0%, respectively), which were significantly greater than vehicle (57.9% and 48.2%; P

Minoxidil is a vasodilator medication known for its ability to promote hair growth. Although it was first introduced as an oral drug to treat hypertension, minoxidil was observed to have the important side-effect of increasing hair growth. This led to the development of a topical formulation as a 2% concentration solution for the treatment of female androgenic alopecia (AGA) and 5% for treating male AGA, which is considered as a first line U.S. Food and Drug Administration (FDA)-approved treatment for AGA in addition to oral 5-alpha-reductase inhibitor (finasteride). The mechanism by which minoxidil promotes hair growth is not fully understood but can be related to increasing blood flow owing to its vasodilator effects. Androgenic alopecia is characterized by the gradual conversion of terminal hairs into vellus hairs. Alterations in the hair cycle include reduced duration of the anagen phase and increased duration of the telogen phase, resulting in shorter hairs and eventual balding. Side effects of topical minoxidil include irritant and allergic contact dermatitis, pruritus, and facial hypertrichosis, which are more often seen with the use of 5% solutions rather than 2%. Herein, we report a 24-year-old woman who developed severe ear and face hypertrichosis after using a topical 5% minoxidil solution. She later had spontaneous resolution of her hypertrichosis three months after stopping it.

Lichen sclerosus (LS) is a chronic inflammatory dermatosis primarily affecting the genitalia, commonly characterized by pearly-white papules and plaques. Although predominantly affecting females, LS can manifest across all age groups, with a bimodal distribution observed in prepubescent girls and postmenopausal women. This case report presents an unusual instance of exclusive extragenital LS in a 10-year-old girl, showcasing hyperpigmented patches and wrinkled plaques resembling lichen planus on her forearms and lower legs. Histopathological analysis confirmed LS, revealing distinctive epidermal changes and lymphocytic infiltrates. The absence of mucosal involvement and unique clinical presentation differentiated this case from typical LS manifestations. Treatment with topical clobetasol propionate demonstrated significant improvement in pruritus. Extragenital LS is infrequent, particularly among children, and its diagnosis necessitates a comprehensive clinicopathological correlation. The reported case contributes valuable insights into this uncommon variant, emphasizing the importance of accurate diagnosis and tailored treatment strategies. Additionally, it highlights the efficacy of high-potency topical corticosteroids in managing this condition.

IntroductionSome caregivers are hesitant about topical fluoride for their children despite evidence that fluoride prevents caries and is safe. Recent work described a five domain model of caregivers' topical fluoride hesitancy. We developed the Fluoride Hesitancy Identification Tool (FHIT) item pool based on the model. This study sought to evaluate the FHIT's psychometric properties in an effort to generate a short, simple to score, reliable, and valid tool that measures caregivers' topical fluoride hesitancy.MethodsIn 2021 and 2022, we conducted an observational, cross-sectional study of caregivers, collecting data from two independent caregiver samples (n1 = 523; n2 = 612). The FHIT item pool included 33 items. We used confirmatory factor analyses (CFA) to examine whether the FHIT items measured five separate domains as hypothesized and to reduce the number of items. We then fit item response theory (IRT) models and computed Cronbach's alpha for each domain. Last, we examined the construct validity of the FHIT and evaluated scoring approaches.ResultsAfter dropping 8 items, CFA supported a five factor model of topical fluoride hesitancy, with no cross-loadings (RMSEA = 0.079; SRMR = 0.057; CFI = 0.98; TLI = 0.98). We further reduced the items to four per domain (20 items total). Marginal alphas showed that the item sets provided reliability of ≥0.90 at hesitancy levels at and above average. The domains correlated more strongly with each other and topical fluoride refusal than with other questions on the survey.DiscussionOur results support the FHIT's ability to reliably and validly measure five domains of topical fluoride hesitancy using the average score of the four items in each domain.

Psoriasis is a chronic immune-mediated disorder that commonly affects adults and children. In recent years, pediatric psoriasis has increased in prevalence and the disease is often associated with various comorbidities and psychological distress. The conventional topical treatments for psoriasis, such as corticosteroids, calcineurin inhibitors, vitamin D analogs, anthralin, and coal tar, are often limited by their side effects, tolerability, and/or efficacy, particularly for use in children and on sensitive and intertriginous areas. Recently, the US Food and Drug Administration approved two new topical non-steroidal agents for treating psoriasis that target different pathogenic pathways than the conventional treatments. Roflumilast is a phosphodiesterase type 4 inhibitor approved for the treatment of plaque psoriasis in patients aged 12 years and older. Tapinarof is a novel aryl hydrocarbon receptor modulator approved for adult psoriasis and currently undergoing studies for pediatric psoriasis. Ongoing efforts are also being made to optimize conventional treatments, for instance, a new foam formulation of halobetasol propionate was recently approved for pediatric psoriasis. Clinical trials of various new drugs targeting one or multiple pathogenic pathways of psoriasis, such as Janus kinase inhibitors, different formulations of phosphodiesterase type 4 inhibitors, and aryl hydrocarbon receptor modulators have also been explored. The recent emergence of novel topical agents provides promising new options for managing pediatric psoriasis with the potential to improve clinical outcomes and quality of life. In this article, we review the mechanism of action, efficacy, and safety profile of novel topical agents and discuss their potential roles in the management of pediatric psoriasis.

Copyright of Revista de Psicoterapia y Psicosomática is the property of Instituto de Estudios Psicosomaticos & Psicoterapia Medica and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

ABSTRACT Rosacea diagnosis and treatment in children are challenging, due to its rarity and to the lack of approved pharmacological agents for its treatment in this age group. In this case series, response to treatment with once daily applications of ivermectin (IVM) 1% cream for 12 weeks in 10 children affected by mild to severe inflammatory rosacea was evaluated clinically by Investigator Erythema Severity Assessment (IESA), Investigator Global Assessment of Severity (IGA‐S), Investigator Global Assessment score of Global Efficacy (IGA‐GE), and instrumentally by dermoscopy and Erythema‐Directed Digital Photography (EDDP). Clinical improvement was achieved at the end of treatment compared to baseline (IESA: 2.3 vs. 0.5; IGA‐S: 2.1 vs. 0.3) and confirmed by IGA‐GE (0 = 55%, 1 = 33%, 3 = 11%) and instrumental monitoring (EDDP: 2.7 vs. 0.6). Once daily IVM application may be an effective therapeutic option for children with rosacea. [ABSTRACT FROM AUTHOR]

The use of nanosized particles is becoming more popular for the topical treatment of skin conditions. In this research work, we created and investigated the effects of solid lipid nanoparticles (SLN) containing hyaluronic acid and tretinoin. Solvent emulsification diffusion method was used to prepare the SLN formulation and characterized for their physicochemical properties. Fourier transform infrared spectroscopy was used to confirm that hyaluronic acid and tretinoin were incorporated in the SLN. Furthermore, X-ray diffractogram, thermal analysis including DSC and TGA and in vitro dissolution, permeation tests were also performed along with microbial assessment. Clinical studies in human were performed to evaluate the effect of the SLN on skin wrinkles. The SLN was 750 ± 31.29 nm in size, with a zeta potential of 13.07 ± 0.75 mV and a narrow polydispersity index of 0.24 ± 0.12. The entrapment efficiency of tretinoin was found to be 90.07 ± 4.79%. Clinical studies in healthy human volunteers demonstrated that 90% of the tested individuals had improved skin conditions (reduction in wrinkles), by at least one grade after 4 weeks of treatment. Regarding the development on SLN, it was found that the internal phase concentration did not considerably affect the physicochemical and microbiological properties. Therefore, Hyaluronic acid has potential for the development of SLN applicable to cosmetic formulations, especially for skin. These findings show that the developed SLN have potential for use as cosmetics in the future. [ABSTRACT FROM AUTHOR]

Objective: We sought to compare the efficacy and safety of encapsulated benzoyl peroxide (E-BPO) cream, 5%, versus vehicle in subjects <65 years of age versus subjects ≥65 with moderate to severe papulopustular rosacea. Methods: This analysis used pooled results from two 12-week, randomized, vehicle-controlled Phase III trials (NCT03564119, NCT03448939) of E-BPO cream, 5%. These trials included 733 subjects randomized 2:1 to E-BPO or vehicle. The primary endpoints were success in the Investigator's Global Assessment (IGA) score and reduction in mean inflammatory lesion count at Week 12. Results: Our analysis shows that E-BPO cream, 5%, was significantly superior to vehicle in achieving IGA success and reducing inflammatory lesions in both age groups. IGA success was achieved in 48.3% of subjects who received E-BPO versus 25.4% for vehicle in the intent-to-treat population. The E-BPO and vehicle IGA success percentages for subjects <65 were 45.7% and 23.8%, respectively, and those for subjects ≥65 were 60.0% and 28.1%, respectively. The absolute reduction from baseline in inflammatory lesions was –19.3 for subjects who received E-BPO versus –11.4 for those who received vehicle. The E-BPO and vehicle absolute reduction values for subjects <65 were –19.6 and –11.2, respectively, and 17.5 and –10.4 for subjects ≥65. There were no significant differences in the frequencies of adverse events or cutaneous tolerability. Limitations: E-BPO was not compared to nonencapsulated BPO. Conclusion: This combined analysis of results from the two Phase III, randomized, double-blind controlled studies of E-BPO cream, 5%, showed it was efficacious, tolerable, and safe, regardless of age. [ABSTRACT FROM AUTHOR]

Purpose: Emerging data suggest that acetaminophen lowers intraocular pressure (IOP) and has the potential to be repurposed as pharmacotherapy to treat open-angle glaucoma. However, pharmacokinetic data are lacking. This study aims to describe the pharmacokinetics of topical acetaminophen and its metabolite [N-arachidonoylaminophenol (AM404)] when administered individually and in combination, and to determine its effect on IOP in the ocular normotensive adult New Zealand White Rabbit (NZWR). Methods: A randomized control trial was conducted using topical 1% acetaminophen and 1% AM404. The study was divided into two sub-studies using both paired-eye and two-eye designs. Results: The mean [95% confidence interval of the mean (95% CI)] concentration of acetaminophen detected in the aqueous humor (AH) was 4.09 ppm (3.18–5.00) at 2 h and 0.92 ppm (0.60–1.24) at 4 h after an immediate dose of topical acetaminophen. The integral IOP, defined as the integral of IOP change from baseline over time, was −5.1 mmHg⋅h (95% CI: −10 to 0.41) for control,−7.5 mmHg⋅h (95% CI: −14 to −1.1) for half-hourly acetaminophen, and −4.4 mmHg⋅h (95% CI: −14 to 5.5) for hourly acetaminophen over a 4-h period. When comparing topical acetaminophen with AM404 dosed half-hourly over a 4-h period, the integral IOP was −2.3 mmHg⋅h (95% CI: −5.9 to 1.3) for control,−2.0 mmHg⋅h (95% CI: −5.6 to 1.7) for AM404, −1.7 mmHg⋅h (95% CI: −4.5 to 1.2) for acetaminophen, and −3.2 mmHg⋅h (95% CI: −5.4 to −0.96) for acetaminophen/AM404 combined. Conclusions: Acetaminophen, but not its metabolite AM404, penetrated the multilayered cornea via passive diffusion in a dose-dependent fashion. There was a nonsignificant tendency to cause a lowering of IOP over the 4-h dosing period with higher AH concentrations of acetaminophen. Topical AM404 did not show a significant IOP-lowering effect. [ABSTRACT FROM AUTHOR]

Objectives: Acute hemorrhage can cause significant morbidity and mortality arising from trauma, bleeding disorders, surgical procedures, or obstetric complications. Surgical hemostasis methods may fail to stop acute bleeding due to the complex bleeding dynamics of each bleeding type. Therefore, developing safe and effective topical hemostatic agents remains crucial. The human amniotic membrane (hAM) has established clinical evidence of effectiveness in promoting wound healing and tissue regeneration. Despite its unique biological and immunologic properties and its structural composition of established hemostatic elements, the hemostatic role of hAM has not been yet explored. The present study aimed to investigate this potential role and to describe the development protocol and characterization of hAM‐derived topical hemostat. Methods: Surface electron microscope (SEM) imaging and Fourier transform infrared (FTIR) spectroscopy were used for characterization, and mouse models with induced peritoneal and tail wound bleeding were employed to evaluate the hemostatic effectiveness using physiological studies, in comparison to a chitosan‐based combat‐scale hemostat. Results: The hAM hemostat showed a distinctive composition by SEM and FTIR. Applying equal masses of the hAM hemostat, the commercial hemostat, or a combination reduced peritoneal wound bleeding time to averages of 108.4, 86.2, and 76.8 s, respectively, compared to the control group (300 s). Tail wound bleeding times were similarly reduced with no significant difference between the hAM and the commercial hemostat (P values = 0.29, 0.34 in peritoneal and tail wounds, respectively). Neither hemostat affected coagulation time. Conclusion: This study describes a simple cost‐effective preparation protocol for a hAM‐based hemostatic agent. The long‐recognized safety, sustainability, and immunotolerance advantages of hAM can establish superiority over commercial hemostats with reported safety concerns. Robust research validation in larger‐scale bleeding models is required for wider applications and severe bleeding types. Synopsis: Herein, the human amniotic membrane (hAM) is investigated for its potential hemostatic properties, reporting the development methods and characterization of the new hAM‐topical hemostat. [ABSTRACT FROM AUTHOR]

Aim: Brown adipose tissue (BAT) thermogenesis has profound energy‐expanding potential, which makes it an attractive target tissue to combat ever‐increasing obesity and its other associated metabolic complications. Although it is fairly accepted that cold is a potent inducer of BAT activation and function, there are limited studies on the mechanisms of pharmacological cold‐mimicking agents, such as the TRPM8 agonist, menthol, on BAT thermogenesis and activation. Methods: Herein, we sought to determine the effect of topical application of menthol (10% w/v [4 g/kg] cream formulation/day for 15 days) on temperature sensitivity behaviour (thermal gradient assay, nesting behaviour), adaptive thermogenesis (infrared thermography, core body temperature), BAT sympathetic innervation (tyrosine hydroxylase immunohistochemistry) and activation (18F‐FDG PET‐CT analysis, Uncoupling Protein 1 immunohistochemistry and BAT gene expression), whole‐body energy expenditure (indirect calorimetry) and other metabolic variables in male C57BL/6N mice. Results: We show that male C57BL/6N mice: (a) develop a warm‐seeking and cold‐avoiding thermal preference phenotype; (b) display increased locomotor activity and adaptive thermogenesis; (c) show augmented sympathetic innervation in BAT and its activation; (d) exhibit enhanced gluconeogenic capacity (increased glucose excursion in response to pyruvate) and insulin sensitivity; and (e) show enhanced whole‐body energy expenditure and induced lipid‐utilizing phenotype after topical menthol application. Conclusions: Taken together, our findings highlight that pharmacological cold mimicking using topical menthol application presents a potential therapeutic strategy to counter weight gain and related complications. [ABSTRACT FROM AUTHOR]

Understanding drug behavior within the skin, especially for photosensitive compounds, is crucial for developing effective and safe topical therapies. This study employs Matrix-Assisted Laser Desorption/Ionization Mass Spectrometry Imaging (MALDI-MSI) and Liquid Chromatography-Mass Spectrometry (LC-MS/MS) to investigate the skin permeation and photostability of selumetinib, a MEK inhibitor used in treating type 1 neurofibromatosis (NF1). The highest amounts of selumetinib in the skin sections were obtained when using the gel formulation, suggesting that it is to be preferred to cream formulations to achieve higher permeation of the drug. Our study also revealed that selumetinib is amenable to photodegradation in ex vivo skin explants, and yields one main degradation product, whose degradation is likely triggered by hydrogen abstraction. MALDI-MSI results showed selumetinib and its degradation product concentrate in skin appendages, indicating these structures might serve as drug reservoirs, potentially prolonging retention and efficacy. This study demonstrates that combining MALDI-MSI with LC/MS-MS can highly contribute to the characterization of the fate of photosensitive compounds in the skin, an essential prerequisite to the development of compound-specific photoprotective measures. It will also pave the way for innovative topical delivery strategies for NF1 treatment. [ABSTRACT FROM AUTHOR]

ABSTRACT Objectives Methods Results Conclusion Nasal anaesthetic‐decongestant sprays are commonly used prior to nasal instrumentation, such as flexible and rigid nasal endoscopy. Co‐phenylcaine (lignocaine 5%, phenylephrine 0.5%, ENT Technologies Pty Ltd., Melbourne, VIC, Australia) is a combination spray commonly used for this purpose. However, lignocaine is less potent than other local anaesthetics, and both active constituents of Co‐phenylcaine have a bitter taste. It was hypothesised that a combination spray containing tetracaine and oxymetazoline would both offer more potent topical anaesthesia and have a better taste.Four anaesthetic‐decongestant nasal sprays were tested in 10 healthy participants (Co‐phenylcaine, and tetracaine 0.5%, 1% and 2% with oxymetazoline 0.05%). Sensory thresholds were sequentially measured at the head of the inferior turbinate using Semmes‐Weinstein monofilaments over the following hour. Participants also rated taste on a Likert‐style scale, and reported whether they experienced subjective numbness of the maxillary teeth.A median peak sensory threshold of 60 g (the maximum tested) was observed with Co‐phenylcaine, but this threshold was exceeded by all the tetracaine‐based sprays. Tetracaine 2% with oxymetazoline 0.05% had a significantly more rapid onset than Co‐phenylcaine (4 min vs. 6 min, p < 0.05) and a longer duration of action. Eight participants reported dental numbness after administration of tetracaine 2% with oxymetazoline 0.05%, but only one participant after Co‐phenylcaine. Tetracaine‐based sprays were generally perceived to taste less unpleasant than Co‐phenylcaine.Tetracaine 2% with oxymetazoline 0.05% is a more potent and rapidly acting anaesthetic‐decongestant spray than Co‐phenylcaine, with a longer duration of action. [ABSTRACT FROM AUTHOR]

Introduction: Topical antifungals for toenail onychomycosis must penetrate the nail to deliver an inhibitory concentration of free drug to the site of infection. In two ex vivo experiments, we tested the ability of topical antifungals to inhibit growth of Trichophyton rubrum and Trichophyton mentagrophytes, the most common causative fungi in toenail onychomycosis. Methods: Seven topical antifungals were tested: three U.S. Food and Drug Administration-approved products indicated for onychomycosis (ciclopirox 8% lacquer; efinaconazole 10% solution; tavaborole 5% solution) and four over-the-counter (OTC) products for fungal infections (tolnaftate 1% and/or undecylenic acid 25% solutions). The ability to inhibit fungal growth was tested in the presence and absence of keratin. Products were applied either to human cadaverous nails or keratin-free cellulose disks prior to placement on an agar plate (radius: 85 mm) seeded with a clinical isolate of T. rubrum or T. mentagrophytes. After incubation, the zone of inhibition (ZI), defined as the radius of the area of no fungal growth, was recorded. Results: In the nail penetration assay, average ZIs for efinaconazole (T. rubrum: 82.1 mm; T. mentagrophytes: 63.8 mm) were significantly greater than those for tavaborole (63.5 mm; 39.1 mm), ciclopirox (7.4 mm; 3.6 mm) and all OTC products (range: 10.5–34.2 mm against both species; all P < 0.001). In the cellulose disk diffusion assay, efinaconazole and tavaborole demonstrated maximal antifungal activity against both species (ZIs = 85 mm); average ZIs against T. rubrum and T. mentagrophytes were smaller for ciclopirox (59.0 and 55.7 mm, respectively) and OTC products (range: 31.2–57.8 mm and 25.7–47.7 mm, respectively). Conclusions: Among all antifungals tested, the ability to penetrate human toenails to inhibit growth of both T. rubrum and T. mentagrophytes was greatest for efinaconazole, followed by tavaborole. These results indicate superior transungual penetration of efinaconazole compared to the other antifungals, suggesting lower keratin binding in the nail. [ABSTRACT FROM AUTHOR]

Objective: Patients with onychomycosis may use nail polish to camouflage affected nails, despite potential interactions between nail polish use and topical onychomycosis treatments. Our objective was to review available data on nail polish use concurrent with topical efinaconazole 10% solution for the treatment of onychomycosis. Methods: We conducted a PubMed search and narrative review of data on effects of nail polish on penetration of efinaconazole and clinical studies of efinaconazole in the treatment of toenail onychomycosis concurrent with nail polish use, including results of an investigator-initiated study of gel nail polish pedicures. Results: In vitro, penetration of efinaconazole through cadaverous nails coated with traditional nail polish was similar to penetration through uncoated nails. In a 52-week clinical study, efinaconazole treatment was associated with similar improvements in onychomycosis severity and clear toenail growth between participants who used traditional nail polish and those who did not use nail polish. In a second clinical study, participants received efinaconazole treatment concurrent with monthly gel nail polish pedicures. After 6 months, 100% of participants tested negative for fungal infection and all experienced visible improvements in treated toenails. Efinaconazole application was associated with degradation of traditional nail polish texture/appearance. In contrast, efinaconazole did not affect the duration, quality, or texture of gel polish. Limitations: Only four small studies have assessed nail penetration and efficacy of efinaconazole 10% solution with concurrent nail polish use. Conclusion: Efinaconazole 10% solution demonstrated efficacy in the treatment of toenail onychomycosis among participants concurrently using toenail polish, with no visible impact on gel-polished nails. [ABSTRACT FROM AUTHOR]

In pharmaceutics, ingredients are classified as active ingredients and excipients. In topical/transdermal phytomedicines, an ingredient may serve both functions. Published information on these dual‐purpose ingredients and their pharmacological relevance is limited. An intriguing scenario arises in traditional Chinese medicine (TCM) formulations, where active ingredients and excipients are undifferentiated. This study analyzes ingredients in TCM topical/transdermal formulations, aiming at harmonization of understanding of TCMs. The most commonly recorded ingredients from such formulations in the Chinese pharmacopoeia 2020 (ChP 2020) are reviewed, aiming at developing innovative topical/transdermal phytomedicines. Current editions of Chinese historical documents were reviewed to explore the principles underlying the use of these ingredients. TCM formulations containing botanical drugs for topical/transdermal application were selected from the ChP 2020. The use of botanical materials in TCM formulations is guided by the "Jun‐Chen‐Zuo‐Shi" principle rooted in Yin‐Yang and the five elements' theories. In the ChP 2020, 155 botanical drugs, along with 40 excipients (from the "procedure" section, focusing on processing and technical parameters), were identified from 34 botanical formulations intended for topical/transdermal application. Pungent and aromatic botanical materials were the most frequently recorded. Adhesive plasters were the most commonly recorded TCM dosage form, employing specific matrix blends. This new perspective of study reveals the prevalence of pungent and aromatic botanical materials, the common use of adhesive plasters, multifunctional properties of botanical oils, and formulation adaptability in TCM topical/transdermal products. These insights should inform novel formulation designs for both pharmaceutical and phytopharmacological research. [ABSTRACT FROM AUTHOR]

Copyright of Cirugía y Cirujanos is the property of Publicidad Permanyer SLU and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Hydrogels have increasingly been used to enhance the effective healing of various wounds, including burn wounds. Similarly, the application of probiotics has recently been explored in wound healing and skin repairs. While probiotics have been consumed to provide therapeutic effects that aid with improving gut health, topical applications have been found to accelerate wound healing both in vitro and in vivo. For wounds that have complex healing mechanisms, such as burn wounds which depend on factors such as the depth of the burn, size of the afflicted area, and cause of the injury, probiotics with or without conventional therapeutic agents topically delivered via hydrogel technology are proven to be effective in the recovery of the damaged skin. This article aims to investigate the microorganisms present in the human skin microbiome and observe the effects of probiotics delivered by hydrogels on burn wound healing. [ABSTRACT FROM AUTHOR]

There is still controversy surrounding the routine use of vancomycin locally in primary orthopaedic surgery procedures. Therefore, the aim of this review is to assess how local vancomycin impacts the rates and microbiology of surgical site infections. A systematic electronic search of MEDLINE, EMBASE, and Web of Science was carried out for all comparative studies comparing locally applied vancomycin to control for primary orthopaedic surgery procedures published before August 14, 2022. A total of 61 studies with 65,671 patients were included for analysis. Forty-six studies used vancomycin powder, 12 studies with grafts soaked in vancomycin, two studies used vancomycin irrigation, and one study administered vancomycin interosseously. There were 15 studies (of 26) in spine surgery, five (of 14) in arthroplasty, ten (of 11) in sports medicine, and two (of five) in trauma surgery that found statistically significant decreases in overall infection rates when applying local vancomycin. Only one study (in spine surgery) found significant increases in infection rates with local vancomycin application. For spine surgery, local vancomycin application had the greatest proportion of gram-negative bacteria (40.7%) isolated compared to S. aureus (42.4%) in controls. In arthroplasty and trauma surgery, there were increases in the proportions of gram-negative bacteria when vancomycin was added. There were no reported systemic adverse reactions associated with local vancomycin use in any of the studies. Applying local vancomycin during primary orthopaedic surgery procedures may reduce the rates of infections in multiple different orthopaedic specialties, particularly in spine surgery and sports medicine. However, careful consideration should be applied when administering local vancomycin during specific orthopaedic procedures given the heterogeneity of included studies and breadth of surgeries included in this review. Level III. A systematic review of level I – III studies. [ABSTRACT FROM AUTHOR]

Relevance.Infantile hemangiomas are the most prevalent vascular tumors in children. Since the natural progression of infantile hemangiomas is typically benign, over 90 % of cases do not require medical intervention. However, treatment is necessary for infantile hemangiomas that present local complications, functional impairments, or arisk of disfigurement. In this article we presented two children with mixed and deep infantile hemangiomas, with satisfactory therapeutic responses after treatment with topical timolol maleate.Conclusion.Timolol maleate is an effective, well-tolerated, and safe treatment option for various types of infantile hemangiomas.

Purpose: Topical clindamycin, a lincosamide antibiotic, is commonly combined with benzoyl peroxide or a retinoid for acne vulgaris (AV) treatment. While oral and topical clindamycin carry warnings/contraindications regarding gastrointestinal (GI) adverse events (AEs), real-world incidence of GI AEs with topical clindamycin is unknown. This review provides background information and an overview of safety data of topical clindamycin for treating AV. Materials and Methods: Available safety data from published literature, previously unpublished worldwide pharmacovigilance data, and two retrospective cohort studies were reviewed. Results and Conclusions: According to pharmacovigilance data, the rate of GI adverse drug reactions with topical clindamycin-containing products was 0.000045% (64/141,084,533). Results from two retrospective medical record studies of patients with AV indicated that physicians prescribe topical clindamycin equally to patients with or without inflammatory bowel disease history, and that rates of pseudomembranous colitis in these patients were low. In 8 published pivotal clinical trials of topical clindamycin for AV, GI AEs were reported in 1.4% of participants. Limitations include under/inaccurate reporting of AEs or prescription data and limited generalizability. This review of published case reports, worldwide pharmacovigilance data, retrospective US prescription data, and clinical trials safety data demonstrates that the incidence of colitis in patients exposed to topical clindamycin is extremely low. [ABSTRACT FROM AUTHOR]

Background: The recognition of an association between the development of acne vulgaris (AV) and pubertal hormonal changes during adolescence dates back almost 100years. Since these formative observations, a significant role of circulating hormones in the pathophysiology of AV and other cutaneous disorders has been established. Aims: This review article aims to provide an overview of clinical and preclinical evidence supporting the influences of androgens on the skin and their therapeutic importance in AV pathophysiology. Results: The cutaneous effects of hormones are attributable, to a large extent, to the influence of steroid hormones, particularly androgens, on sebocyte development and sebum production in both sexes. Androgen-mediated excess sebum production is implicated as a necessary early step in AV pathophysiology and is therefore considered an important therapeutic target in AV treatment. Although the local production and/or activity of androgens within the skin is believed to be important in AV pathophysiology, it has received limited therapeutic attention. Conclusions: We have summarized the current evidence in support of the therapeutic benefits of targeted hormonal treatment to decrease androgen-stimulated sebum production for the effective and safe treatment of AV in both male and female patients. [ABSTRACT FROM AUTHOR]

Niacinamide, an active form of vitamin B3, is recognised for its significant dermal benefits including skin brightening, anti-ageing properties and the protection of the skin barrier. Its widespread incorporation into cosmetic products, ranging from cleansers to serums, is attributed to its safety profile and proven efficacy. Recently, topical niacinamide has also been explored for other pharmaceutical applications, including skin cancers. Therefore, a fundamental understanding of the skin permeation behaviour of niacinamide becomes crucial for formulation design. Given the paucity of a comprehensive review on this aspect, we provide insights into the mechanisms of action of topically applied niacinamide and share the current strategies used to enhance its skin permeation. This review also consolidates clinical evidence of topical niacinamide for its cosmeceutical uses and as treatment for some skin disorders, including dermatitis, acne vulgaris and actinic keratosis. We also emphasise the current exploration and perspectives on the delivery designs of topical niacinamide, highlighting the potential development of formulations focused on enhancing skin permeation, particularly for clinical benefits. [ABSTRACT FROM AUTHOR]

Background: Transferosomes provide delivery of the drug into systemic circulation via the skin as a topical delivery system. So, this study started with the objective of formulating Etodolac transfersomal gel to enhance its skin permeation. Methodology: A total of nine transferosomes (ET-1 to ET-9) containing lecithin, different grades of span and tween, were successfully prepared using a rotary film evaporator. Results and Discussion: After primary evaluation, results were as particle sizes ranged from 222 to 421 nm, zeta potential shows results from –18.50 to –62.53 mV with PDI values 0.254 to 0.303, and the entrapment efficiency (EE%) of Etodolac in the transferosomes ranged from 54.15% to 80.25%. Additionally, the transfersomes formulations were included in carbopol 940 gels (ETC-1 to ETC-9 and EC-0 without transferosomes) and assessed for various characteristics like color, pH, homogeneity, spreadability, viscosity, and in vitro drug release study. Optimized formulation (ET4 and ETC4) underwent further analysis using SEM, TEM, DSC, FTIR, XRD, ex vivo skin permeation, skin irritation and in vivo studies. The in vivo results were compared. % edema inhibition maximum was observed with optimized transfersomal gel formulation (ETC4) as compared to the marketed formulation and plain Carbopol gel when the study was completed after 8 hrs. Conclusion: After this research, it is suggested that Etodolac Transfersomal gel (ETC4) can be considered as an alternate drug carriers system for topical delivery and it could be used to treat Rheumatoid Arthritis

Abstract Background The administration of tranexamic acid (TXA) during spinal surgery has been shown to reduce blood loss. However, the efficacy and safety of intravenous TXA (ivTXA) and topical TXA (tTXA) are poorly documented. The present meta-analysis aimed to compare the efficacy and safety of ivTXA and tTXA administration in spinal surgery. Methods Potentially relevant academic articles were identified from PubMed, Ovid, Cochrane Library, CNKI database, and Wanfang Data from the date of inception until March 1, 2024. Randomized controlled trials (RCTs) and nonrandomized controlled trials (non-RCTs) were included in our meta-analysis if they compared the efficacy and safety of ivTXA versus tTXA administration during spinal surgery. Secondary sources were identified from the references of the included literature. The meta-analysis was performed in accordance with the guidelines of the Cochrane Reviewer’s Handbook and the PRISMA statement. Data were summarized using RevMan 5.3 software from Denmark. Results Four RCTs and one non-RCT met our inclusion criteria. The pooled outcomes demonstrated that ivTXA groups compared with tTXA groups had significantly less amount of total blood loss [weighted mean difference (WMD)=-159.55, 95% CI (-181.91,-137.19), P

Microemulsions (MEs) and nanoemulsions (NEs) are dispersions of two immiscible liquids which are usually transparent/translucent. Several reports are available on uses of MEs/NEs to increase efficacy of the loaded active ingredient(s) in topical dosage forms. This review aims to describe brief applications of MEs/NEs in common skin diseases as well as skincare products. Advantages of MEs/NEs in comparison with the traditional bulk form, including their improved efficacy and safety, have been discussed to highlight the importance of use of such delivery systems. The review briefs mechanism of action of MEs/NEs in enhancing delivery of the cargo. Furthermore, applications of MEs/NEs in common skin diseases including infectious rashes, pigmentation disorders (hyperpigmentaion and hypopigmentation), wound healing, skin cancers and scaling patches and plaques/papulosquamous disorders (psoriasis, atopic dermatitis and acne) have been discussed. MEs/NEs in skin care products have also been reviewed here.

Background: Alopecia areata (AA) is an autoimmune disease of the hair follicles. Although some cases resolve spontaneously, many patients require some form of treatment, including corticosteroids and vitamin D analogues, among others. Cytokine signaling in autoimmune disorders and their inhibition have been the prime objective in therapeutic research over the past few years. Janus kinase inhibitors such as tofacitinib have shown efficacy in the treatment of AA. The present study aimed to evaluate the efficacy of a novel formulation of topical tofacitinib compared to vehicle in patients with AA. Materials and Methods: A prospective, non-blinded, intrasubject vehicle-controlled study was conducted in patients with AA for a total duration of 6 months. A 2% tofacitinib citrate ointment was compounded in the pharmacy. Tofacitinib tablets (5 mg) were crushed and mixed in white soft paraffin to produce 2% ointment. A thin layer of this ointment was applied to the treatment patch, while the control patches received the application of the vehicle twice daily. Both patches in each patient were evaluated for percentage change in severity of alopecia tool [SALT] score after 24 weeks as the primary outcome. This was graded as excellent response (>50% improvement), intermediate response (25–50%), mild response (5–25%), and no response (50% change in the SALT score) over six months of treatment. The mean SALT score was significantly reduced from baseline to six months of treatment (mean [95% CI]: 4.3 [1.9–6.3]; P = 0.001). The control patch had substantially higher positive results in the final hair pull test, indicating disease activity (Treatment: 10% vs. Control: 86.7%, P < 0.001). Compared to the control patch, the prevalence of upright hair (10.0% vs. 80.0%) and terminal hair (3.3% vs. 70.0%) were significantly higher in the treatment patch (P < 0.001). No serious adverse effects were reported during the study duration. Limitations: Sample size was small and the followup was not long enough to study the full effects of tofacitinib, as well as maintenance of remission or relapse after discontinuation. Conclusion: Topical tofacitinib proved to be an efficacious and well-tolerated treatment modality for AA with no adverse effects reported during this study.

Jiawen Zhang,1,&ast; Duoduo Gu,2,&ast; Yang Yan,3,&ast; Ruoxin Pan,2 Hui Zhong,4,5 Chengfeng Zhang,1 Yang Xu2 1Department of Dermatology, Huashan Hospital of Fudan University, Shanghai, People’s Republic of China; 2Department of Dermatology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, People’s Republic of China; 3Department of Cardiology, Ren Ji Hospital of Shanghai Jiao Tong University, Shanghai, People’s Republic of China; 4State Key Laboratory of Natural Medicines, China Pharmaceutical University, Nanjing, People’s Republic of China; 5School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Chengfeng Zhang; Yang Xu, Email e3dangdang@hotmail.com; yangxu@njmu.edu.cnAbstract: Rosacea is a chronic inflammatory skin disease that affects a patient’s appearance and quality of life. It mainly affects the midface region and presents as erythema, flushing, telangiectasia, papules, pustules, and rhinophyma. Despite its prevalence, the precise pathophysiology of rosacea remains unknown, and novel pharmacological therapies are currently under investigation. Tranexamic acid (TA) is a synthetic, lysine-like compound that competitively inhibits fibrinogen production by synthesizing fibrinolytic enzymes. In addition to its popular application in hemorrhage treatment, TA has been used to manage a number of skin conditions, including melasma, chronic urticaria, and angioedema. TA is a better option for melasma treatment. However, the role of TA in treating rosacea has not yet been systematically elucidated. In this study, we reviewed all available literature on the use of TA for rosacea treatment. The included articles examined the therapeutic effects of TA in patients with rosacea, including traditional methods such as oral and topical administration and more novel approaches such as intradermal injections, microneedling, and laser-assisted delivery. Several recent clinical studies demonstrated that TA alleviates rosacea symptoms by restoring the permeability barrier, ameliorating the immune reaction, and inhibiting angiogenesis. In this review, we summarized the function and potential application of TA in rosacea treatment, aiming to facilitate the implementation of clinical applications.Keywords: rosacea, tranexamic acid, topical, oral, microinjection

Abstract Introduction The World Health Organization (WHO) places great importance on oral health promotion programs in schools, given that approximately one billion people worldwide are students. This demographic not only includes the students themselves, but also extends to school staff, their families, and the broader community, all of whom are interconnected. The objectives of this study were firstly to assess the knowledge of health personnel conducting fluoride varnish treatment (FVT) in schools, and secondly to solicit their views on the effectiveness of their training methods. Methods Data was collected from health personnel involved in FVT in schools, supervised by medical universities in Tehran province, using a questionnaire. The questionnaire was divided into four sections: demographic information, methods of receiving FVT training, respondents’ knowledge regarding FVT, and opinions about the effectiveness of FVT training methods. The questionnaire was distributed via social media, phone conversations, and email. The collected data was analyzed using Mann-Whitney in SPSS Version 26. A regression model was also fitted to the data. Results The present study included 403 participants. Among various educational methods, it was found that participation in previous workshops (P = 0.001) and FVT workshops (P = 0.013) was significantly correlated with a higher FVT knowledge score. Additionally, participation in previous oral health promotion programs was significantly associated with a higher knowledge score (P

Dry skin is a common dermatological condition that frequently affects the elderly. A contributing cause to dry skin is a reduced concentration of hyaluronic acid (HA) in both the epidermis and dermis. The effectiveness of moisturizer containing HA as a therapy for dry skin is impacted by its specific molecular weight. Low molecular weight HA (LMWHA) is believed to be more effective in replenishing skin hydration in aging skin compared to High Molecular Weight HA (HMWHA) due to its ability to penetrate the stratum corneum. However, there is a lack of clinical research supporting this claim. A double-blind, randomized controlled trial was conducted on 36 residents of a nursing home in Jakarta. The participants, aged between 60 and 80 years, had been diagnosed with dry skin. Each test subject was administered three distinct, randomized moisturizing lotions (LMWHA, HMWHA, or vehicle), to be topically applied to three separate sites on the leg. Skin capacitance (SCap), transepidermal water loss (TEWL), and specified symptom sum score (SRRC) were measured at weeks 0, 2, and 4. After four weeks of therapy, area that was treated with LMWHA showed greater SCap values compared to the area treated with HMWHA (56.37 AU vs. 52.37 AU, p = 0.004) and vehicle (56.37 AU vs. 49.01 AU, p < 0.001). All groups did not show any significant differences in TEWL and SRRC scores. No side effects were found in all groups. The application of a moisturizer containing LMWHA to the dry skin of elderly resulted in significant improvements in skin hydration compared to moisturizers containing HMWHA and vehicle. Furthermore, these moisturizers demonstrated similar safety in treating dry skin in the elderly. ClinicalTrials.gov Identifier NCT06178367, . [ABSTRACT FROM AUTHOR]

Introduction: Melasma is a chronic hyperpigmentation disorder, and its treatment poses a challenge to dermatologists due to its chronicity and resistance to conventional therapies. Oral isoniazid is used for the treatment of tuberculosis. One of us had previously showed that topical isoniazid exerts a strong depigmenting action in animal models. In this clinical trial, we assessed the therapeutic effect of topical isoniazid on melasma. Methods: Twenty female patients suffering from epidermal melasma were enrolled and divided equally into two groups. The treatment group received topical isoniazid 10%, and the control group received the cold cream vehicle as the placebo. All participants were advised to avoid sunlight and used SPF 50 sunscreen. Patients applied topical agents once daily at night for 3 months. The melanin and erythema indices were measured by colorimetric evaluations at baseline and after 4, 8, and 12 weeks of treatment. At these time points, the (mMASI) score was also determined, as was the subjective evaluation through Melasma Quality of Life Scale (MELASQOL) scores. Blood tests were performed to evaluate CBC and the liver enzymes. Results: All patients completed the 12‐week study. In the treatment group, a significant decrease in melanin index from 63.77 ± 6.27 at baseline to 55.92 ± 5.79 was recorded (p = 0.001). Very minimal clinical changes were also seen in the control group and melanin index was decreased from 62.65 ± 2.23 to 61.25 ± 2.34 (p = 0.004). Clinically significant differences were observed in the rate of changes between both groups. These findings indicate that topical isoniazid has significant depigmenting effects compared to the placebo (p = 0.001). The erythema index remained unchanged in both groups. In the treatment group, the mMASI score was 5.63 ± 3.28 at baseline and 2.13 ± 1.71 at the last follow‐up, significantly reduced compared to the control group (p = 0.002). The MELASQOL score indicated a significant improvement in the quality of life in the treatment group. Conclusion: This clinical trial shows for the first time that topical isoniazid is effective in treating melasma. Further clinical trials are necessary to confirm the efficacy and tolerability of topical isoniazid in comparison with other skin‐depigmenting compounds. [ABSTRACT FROM AUTHOR]

Efficacy and/or safety profiles limit topical psoriasis treatments. Evaluate long-term effects of once-daily roflumilast cream 0.3% in patients with psoriasis. In this open-label phase 2 trial, adult patients (N = 332) with psoriasis who completed the phase 2b parent trial or were newly enrolled applied roflumilast once-daily for 52 weeks. Safety and effectiveness were assessed. Overall, 244 patients (73.5%) completed the trial; 13 patients (3.9%) discontinued due to adverse events (AEs) and 3 (0.9%) due to lack of efficacy. Twelve patients (3.6%) reported treatment-related AEs; none were serious. ≥97% of patients had no irritation. No tachyphylaxis was observed with 44.8% of the patients achieving Investigator Global Assessment (IGA) Clear or Almost Clear at Week 52. Intertriginous-IGA and Psoriasis Area and Severity Index (PASI) were not evaluated in all patients. In this long-term trial, once-daily roflumilast cream was well-tolerated and efficacious up to 64 weeks in patients in the earlier trial, suggesting it is suitable for chronic treatment, including the face and intertriginous areas. [ABSTRACT FROM AUTHOR]

Dynamic wrinkle reduction continues to challenge aesthetic dermatology, predominantly addressed through Botulinumtoxin (Botox) injections. Despite Botox's robust efficacy with up to an 80% reduction in wrinkle visibility within just one week, its invasive administration and specific mechanism of soluble N-ethylmaleimide-sensitive factor attachment protein receptor (SNARE) complex inhibition prompt the exploration of safer, non-invasive alternatives. This review critically assesses recent innovations in non-invasive effects, with a focus on peptides and botanical extracts that exhibit a diverse array of mechanisms including SNARE complex inhibition, modulation of calcium and sodium channels, and interactions with acetylcholine receptors, contributing to their effectiveness in muscle relaxation on dynamic wrinkle approaches. Noteworthy peptides such as Argireline and SYN-Ake replicate the neuromodulatory effects of Botox, achieving up to a 52% reduction in wrinkles within four weeks without injections. Moreover, botanical extracts meet the rising demand for clean beauty solutions by enhancing skin elasticity and health through gentle yet potent mechanisms. However, the main concern with peptides is their low absorption rate, with only six clinical validations regarding Botox-like peptide anti-wrinkle efficacy available. These advancements not only deepen our understanding of cosmetic dermatology but also significantly influence market dynamics and consumer behavior, underscoring their pivotal role in redefining the future landscape of anti-aging effects. [ABSTRACT FROM AUTHOR]

Skin disorders have an important psychosocial impact on the life of the affected patient. Skin disorders are usually treated by using topical drug delivery systems like creams and gels. These conventional topical drug delivery systems display various adverse effects (burning, itching, inflammation, etc.) reducing the therapeutic efficacy of drugs. Therefore, pharmaceutical scientists are trying to develop new delivery vehicles to treat dermatological disorders. Polymeric microsponges have shown their potential to deliver various therapeutic agents effectively through the topical route in the last decade. Their physicochemical properties like size, high drug entrapment (%), and extended drug release make them superior to other microcarriers explored for topical delivery. This present review discloses about methods of preparation, characterization parameters, and the role of polymeric microsponges for the topical delivery of a variety of drugs. The literature investigation for this review was done by exploring search engines like Google Scholar and Pubmed. This review will be useful for the researchers involved in the work of the development of new delivery vehicles for the topical route. [ABSTRACT FROM AUTHOR]

Purpose: To develop a toolkit of test methods for characterizing potentially critical quality attributes (CQAs) of topical semisolid products and to evaluate how CQAs influence the rate and extent of active ingredient bioavailability (BA) by monitoring cutaneous pharmacokinetics (PK) using an In Vitro Permeation Test (IVPT). Methods: Product attributes representing the physicochemical and structural (Q3) arrangement of matter, such as attributes of particles and globules, were assessed for a set of test acyclovir creams (Aciclostad® and Acyclovir 1A Pharma) and compared to a set of reference acyclovir creams (Zovirax® US, Zovirax® UK and Zovirax® Australia). IVPT studies were performed with all these creams using heat-separated human epidermis, evaluated with both, static Franz-type diffusion cells and a flow through diffusion cell system. Results: A toolkit developed to characterize quality and performance attributes of these acyclovir topical cream products identified certain differences in the Q3 attributes and the cutaneous PK of acyclovir between the test and reference sets of products. The cutaneous BA of acyclovir from the set of reference creams was substantially higher than from the set of test creams. Conclusions: This research elucidates how differences in the composition or manufacturing of product formulations can alter Q3 attributes that modulate myriad aspects of topical product performance. The results demonstrate the importance of understanding the Q3 attributes of topical semisolid drug products, and of developing appropriate product characterization tests. The toolkit developed here can be utilized to guide topical product development, and to mitigate the risk of differences in product performance, thereby supporting a demonstration of bioequivalence (BE) for prospective topical generic products and reducing the reliance on comparative clinical endpoint BE studies. [ABSTRACT FROM AUTHOR]

Background: Alopecia areata (AA) is an autoimmune disease of the hair follicles. Although some cases resolve spontaneously, many patients require some form of treatment, including corticosteroids and vitamin D analogues, among others. Cytokine signaling in autoimmune disorders and their inhibition have been the prime objective in therapeutic research over the past few years. Janus kinase inhibitors such as tofacitinib have shown efficacy in the treatment of AA. The present study aimed to evaluate the efficacy of a novel formulation of topical tofacitinib compared to vehicle in patients with AA. Materials and Methods: A prospective, non‑blinded, intrasubject vehicle‑controlled study was conducted in patients with AA for a total duration of 6 months. A 2% tofacitinib citrate ointment was compounded in the pharmacy. Tofacitinib tablets (5 mg) were crushed and mixed in white soft paraffin to produce 2% ointment. A thin layer of this ointment was applied to the treatment patch, while the control patches received the application of the vehicle twice daily. Both patches in each patient were evaluated for percentage change in severity of alopecia tool [SALT] score after 24 weeks as the primary outcome. This was graded as excellent response (>50% improvement), intermediate response (25–50%), mild response (5–25%), and no response (<5% improvement). Trichoscopy and hair pull test were evaluated as secondary outcomes. Results: The present study included 30 patients with AA having a median age of 27 years. Among 30 patients, 40% achieved excellent response (>50% change in the SALT score) over six months of treatment. The mean SALT score was significantly reduced from baseline to six months of treatment (mean [95% CI]: 4.3 [1.9–6.3]; P = 0.001). The control patch had substantially higher positive results in the final hair pull test, indicating disease activity (Treatment: 10% vs. Control: 86.7%, P < 0.001). Compared to the control patch, the prevalence of upright hair (10.0% vs. 80.0%) and terminal hair (3.3% vs. 70.0%) were significantly higher in the treatment patch (P < 0.001). No serious adverse effects were reported during the study duration. Limitations: Sample size was small and the followup was not long enough to study the full effects of tofacitinib, as well as maintenance of remission or relapse after discontinuation. Conclusion: Topical tofacitinib proved to be an efficacious and well‑tolerated treatment modality for AA with no adverse effects reported during this study. [ABSTRACT FROM AUTHOR]

Les glucocorticoïdes sont largement utilisés pour le traitement de diverses maladies et affections dans un certain nombre de spécialités. Les effets néfastes des glucocorticoïdes oraux sur la santé osseuse sont bien documentés et l'ostéoporose cortico-induite est la cause la plus répandue d'ostéoporose provoquée par des médicaments et de fractures. On ne sait toutefois pas avec certitude si, ni dans quelle mesure, les glucocorticoïdes administrés par d'autres voies ont des effets sur le squelette. Cette revue présente les résultats disponibles à propos des effets des glucocorticoïdes administrés par voie inhalée, épidurale, intra-articulaire et topique sur les paramètres osseux. Bien que les données probantes soient limitées et peu robustes, il semble qu'une petite proportion des glucocorticoïdes administrés puisse être absorbés, pénétrer dans la circulation systémique et avoir des effets néfastes sur le squelette. Les glucocorticoïdes puissants, les fortes doses et une longue durée de traitement pourraient entraîner un risque accru de perte osseuse et de fractures. On trouve peu de données, et celles qui sont disponibles concernent uniquement les glucocorticoïdes inhalés, sur l'efficacité des anti-ostéoporotiques chez les patients recevant une corticothérapie administrée par d'autres modes que la voie orale. Des études complémentaires sont nécessaires pour clarifier la relation entre les différentes voies d'administration des glucocorticoïdes et les paramètres osseux et contribuer à formuler des recommandations de prise en charge optimale de ces patients. Glucocorticoids (GCs) are widely used by several specialties for the treatment of a variety of diseases and conditions. The unfavorable effect of oral GCs on bone health is well-documented. The ensuing from their use glucocorticoid-induced osteoporosis (GIOP) is the most common cause of medication-induced osteoporosis and fractures. It is uncertain, however, if, and in what extent, GCs administered by other routes affect the skeleton. In the present review, we quote current evidence on the effect of inhaled GCs, epidural and intra-articular steroid injections, and topical GCs on bone outcomes. Although evidence is limited and weak, it seems that a small proportion of the administered GCs may be absorbed, enter the systemic circulation, and adversely affect the skeleton. Potent GCs, higher doses, and longer treatment duration seem to infer the greater risk for bone loss and fractures. There are scarce data, and only for inhaled GCs, regarding the efficacy of antiosteoporotic medications in patients receiving GCs through routes other than oral. Further studies are needed to clarify the relationship between GC administration through these routes and bone outcomes and to help establishing guidelines for the optimal management of such patients. [ABSTRACT FROM AUTHOR]

Microemulsions (MEs) and nanoemulsions (NEs) are dispersions of two immiscible liquids which are usually transparent/translucent. Several reports are available on uses of MEs/NEs to increase efficacy of the loaded active ingredient(s) in topical dosage forms. This review aims to describe brief applications of MEs/NEs in common skin diseases as well as skincare products. Advantages of MEs/NEs in comparison with the traditional bulk form, including their improved efficacy and safety, have been discussed to highlight the importance of use of such delivery systems. The review briefs mechanism of action of MEs/NEs in enhancing delivery of the cargo. Furthermore, applications of MEs/NEs in common skin diseases including infectious rashes, pigmentation disorders (hyperpigmentaion and hypopigmentation), wound healing, skin cancers and scaling patches and plaques/papulosquamous disorders (psoriasis, atopic dermatitis and acne) have been discussed. MEs/NEs in skin care products have also been reviewed here. [ABSTRACT FROM AUTHOR]

In situ gelling systems represent a burgeoning paradigm in ocular drug administration, addressing intrinsic challenges posed by extant ocular formulations, such as compromised bioavailability and constraints in traversing the corneal barrier. This systematic review endeavours to comprehensively examine the contemporary landscape of research in this domain, focusing on the nuanced capabilities of in situ gelling systems to optimize drug delivery and enhance therapeutic outcomes, without much technological complexity. Employing a meticulous search strategy across diverse databases for publications and patents spanning the years 2015 to 2023 a total of 26 research papers and 14 patents meeting stringent inclusion criteria were identified. Synthesizing the collective insights derived from these investigations, it becomes evident that in situ gelling systems confer an ability to protract the residence time of formulations or active pharmaceutical ingredients (APIs) within the ocular milieu. This sustained presence engenders extended drug release kinetics, thereby fostering improved patient compliance and mitigating the proclivity for side effects attendant to frequent dosing. These salutary effects extend to diminished systemic drug absorption, augmented ocular bioavailability, and the prospect of reduced dosing frequencies, thereby amplifying patient adherence to therapeutic regimens. Intriguingly, the protective attributes of in situ gelling systems extend to the establishment of an ocular surface barrier, thereby abating the susceptibility to infections and inflammatory responses. In summation, this review underscores the auspicious potential of in situ gelling systems as a transformative approach to advancing ocular drug delivery, warranting sustained research endeavours and developmental initiatives for the betterment of global patient outcomes. [Display omitted] • In situ gels for ocular delivery offer simple alternative to conventional low performing drops • Various polymer and polymer combinations are used for in situ gelling, each with distinct mechanism and advantages. • Gelling upon application enhances drug retention and improves ocular bioavailability. • In situ gel-forming systems represent advanced ocular drug delivery, with enhanced therapeutic outcomes for eye disorders. • This review covers recent research and patents, focusing on ophthalmic applications of in situ gels. [ABSTRACT FROM AUTHOR]

The development of ethylcellulose-based polymeric microsponges for the topical delivery of therapeutic agents has attracted the interest of pharmaceutical scientists around the globe in recent years. This work represents preparation, optimization (using Box–Behnken design [BBD]), and characterization (in-vitro and ex-vivo) of ethylcellulose microsponges loaded with vanillin for effective topical delivery to treat wounds. Vanillin-ethylcellulose microsponges were prepared by using quasi-emulsion solvent diffusion and optimized formulation (F9) (containing 100 mg ethylcellulose, 10 mL dichloromethane, 100 mg vanillin, and 90 mg polyvinyl alcohol) developed showed particle size (90.3 ± 2.9 µm), high entrapment of vanillin (79.0 ± 2.8%), and optimum colloidal properties (zeta potential = −37.91 ± 2.44 mV; polydispersity index (PDI) = 0.224 ± 0.23). Optimized formulation extended the release of vanillin (96.68 ± 3.11%) in-vitro for 24 h. Vanillin-ethylcellulose microsponges (F9) dispersed in Carbopol 940 gel showed limited ex-vivo skin permeation (steady-state flux, JSS = 243.7 ± 6.2 µg/cm2/h) and higher skin retention (82.46 ± 6.74%) for 24 h in pig ear skin compared to plain vanillin Carbopol 940 gel (steady-state flux, JSS = 1350 ± 10.8 µg/cm2/h, skin retention = 33.66 ± 4.53%). Results of confocal laser scanning microscopy (CLSM) of Vanillin-ethylcellulose microsponges (F9) Carbopol 940 gel revealed accumulation of microsponges in the stratum corneum layer of skin as a depot. Microsponges-based Carbopol 940 gel also displayed excellent in-vitro antibacterial activity (zone of inhibition = 24.2 ± 1.3 mm) against Staphylococcus aureus for 24 h compared to plain vanillin Carbopol 940 gel (zone of inhibition = 10.30 ± 1.2 mm) that was considered good for its wound healing activity. Therefore, developed vanillin-loaded ethylcellulose microsponges could be effectively used in the treatment of wounds by reducing side effects associated with vanillin and promoting its localized delivery in Carbopol 940 gel form. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to prepare and evaluate chitosan (CS) gel containing metformin hydrochloride (MET)-loaded polycaprolactone (PCL) nanoparticles (NPs) for topical treatment of melanoma. Significance: Topical administration of MET-PCL NPs-CS gel improves penetration of drug, decreases side effects, and increases efficacy of treatment. Methods: MET-PCL NPs were prepared by double emulsion method. Particle size, charge, encapsulation efficiency (EE), release, and morphology were evaluated. MET-PCL NPs-CS gel formulation was characterized in terms of organoleptic properties, pH, gelling time, viscosity, spreadability, release, and morphology. Cytotoxicity was performed on B16F10 cells. Ex vivo permeability was done with pig skin. Results: The size, charge, and EE were found to be 180 ± 10 nm, −11.4 mV, and 93%. SEM images showed that NPs were spherical and smooth. An initial burst release followed by a slower release was observed. MET-PCL NPs-CS gel was found to be transparent. The pH was 4.9 ± 0.05. The gelation time was 1.6 ± 0.2 min. The viscosity results confirm pseudoplastic behavior of gel. The spreadability by % area was 392 ± 6.4 cm. The images showed that gelling network of CS gel was composed of suspended NPs. The viscosity was between 554 and 3503 cP. MET-PCL NPs-CS gel showed prolonged release up to 72 h. On B16F10 cells, gel showed higher cytotoxicity compared to MET solution. MET-PCL NPs-CS gel had twofold higher permeability in pig skin compared with MET-CS gel. Conclusion: Topical administration of MET-PCL NPs-CS gel into the skin resulted in improved dermal penetration and this promising approach may be of value in effective treatment of melanoma and other skin cancers. [ABSTRACT FROM AUTHOR]

This study aimed to compare the clinical effectiveness of resin-based fissure sealants (FS) and fluoride varnish (FV) in children at high caries risk. A practice-based split-mouth randomized clinical trial was conducted at 9 Public Dental Service (PDS) clinics in Norway. In total, 409 children age 6 to 10 y at high caries risk (d3mft > 0) meeting inclusion criteria were recruited by dentists and dental hygienists during routine examination. Eligibility criteria were 2 fully erupted first permanent molars (FPMs) in the same jaw, with sound occlusal surfaces or with initial caries. Participation was voluntary, caregivers and eligible children were informed about the study, and written parental consent was obtained. FS and FV were randomly applied on contralateral FPMs in the same jaw, with each participant serving as their own control. FS was applied at baseline and thereafter maintained according to clinicians' conventional procedures, whereas FV was applied at baseline, 6 mo, and 12 mo. The study outcome was success, with no need for invasive treatment (caries control), while failure was defined as dentin carious lesion or restoration. Two-level mixed-effects logistic regression analysis was used to compare FS and FV groups. Of 409 recruited children, 369 (90%) children/tooth pairs were examined after 36 mo. Intention-to-treat analysis showed 94.1% adjusted predicted probability (aPP) of success (95% confidence interval [CI] 91.7 to 96.4) in the FS group and 89.6% aPP (95% CI 86.5 to 92.7) in the FV group. In the adjusted analysis, the FV group had a lower OR for success compared with the FS group (OR 0.54, 95% CI 0.24 to 0.87). In the population studied, the clinical effectiveness of FS was statistically significantly higher compared with FV but below the estimated minimal clinically important difference of 10%. [ABSTRACT FROM AUTHOR]

Background: Radioactive tracer injections for breast cancer sentinel lymph node mapping can be painful. In this randomized trial, we compared four approaches to topical pain control for radiotracer injections. Methods: Breast cancer patients were randomized (9 April 2021–8 May 2022) to receive the institutional standard of ice prior to injection (n = 44), or one of three treatments: ice plus a vibrating distraction device (Buzzy®; n = 39), 4% lidocaine patch (n = 44), or 4% lidocaine patch plus ice plus Buzzy® (n = 40). Patients completed the Wong-Baker FACES® pain score (primary outcome) and a satisfaction with pain control received scale (secondary). Nuclear medicine technologists (n = 8) rated perceived pain control and ease of administration for each patient. At study conclusion, technologists rank-ordered treatments. Data were analyzed as intention-to-treat. Wilcoxon rank-sum tests were used to compare pain scores of control versus pooled treatment arms (primary) and then control to each treatment arm individually (secondary). Results: There were no differences in pain scores between the control and treatment groups, both pooled and individually. Eighty-five percent of patients were 'satisfied/very satisfied' with treatment received, with no differences between groups. No differences in providers' perceptions of pain were observed, although providers perceived treatments involving Buzzy© more difficult to administer (p < 0.001). Providers rated lidocaine patch as the easiest, with ice being second. Conclusion: In this randomized trial, no differences in patient-reported pain or satisfaction with treatment was observed between ice and other topical treatments. Providers found treatments using Buzzy® more difficult to administer. Given patient satisfaction and ease of administration, ice is a reasonable standard. [ABSTRACT FROM AUTHOR]

The goal of this study was to evaluate whether topical administration of tacrolimus (TAC) and mycophenolic acid (MPA) at the transplant site enables vascularized composite allograft (VCA) survival with significant minimization of the dose and adverse effects of systemic TAC (STAC) immunosuppression. Lewis (Lew) rats received orthotopic hind limb allotransplants from fully mismatched Brown Norway (BN) donors. Group 1 (Controls) received no treatment. Other groups were treated with STAC at a dose of 1 mg/kg/day for 7 days. On post-operative day (POD) 8, the STAC dose was dropped to 0.1 mg/kg/day for Group 2 and maintained at 1 mg/kg for Group 3. Group 4 received topical application of TAC and MPA on the transplanted (Tx) limb starting POD 8 without STAC. Group 5 received topical TAC and MPA on the contralateral non-Tx limb and Group 6 received topical TAC and MPA on the Tx limb starting POD 8 along with low dose STAC (0.1 mg/kg/day). Treatment was continued until the study end point was reached, defined as either grade 3 rejection or allograft survival exceeding 100 days..We conducted sequential LC-MS/MS measurements to assess TAC and MPA concentrations in both blood/plasma and allograft tissues. Additionally, we evaluated markers indicative of organ toxicity associated with STAC immunosuppression. Compared to controls, topical therapy with TAC+MPA significantly prolonged allograft survival beyond 100 daysat very low dose STAC (0.1 mg/kg/day) (Group 6). The histopathological assessment of the grafts was consistent with the clinical outcomes..Drug levels in blood/plasma remained low or undetectable, while allograft tissues showed higher drug concentrations compared to contralateral limb tissues (P <0.05).. Urinary creatinine clearance remained within the normal range at 2.5 mL/min. Combination therapy with topical TAC and MPA synergizes with a very low dose, corticosteroid- free-STAC regimen and facilitates rejection-free, prolonged VCA survival without morbidity. [ABSTRACT FROM AUTHOR]

Introduction: Psoriasis involvement in special areas (e.g., scalp or nails) is associated with a great disease burden yet it is often inadequately treated with topical treatments. The efficacy and tolerability of apremilast plus existing topical therapy in Japanese patients with mild to moderate plaque psoriasis were demonstrated in PROMINENT, a phase 3b, multicenter, open-label, single-arm study. We evaluated the efficacy of apremilast across disease severities and special areas involved in these patients. Methods: In PROMINENT, patients received apremilast 30 mg twice daily for 16 weeks in addition to their existing topical therapy, with the option of topical therapy reduction at the discretion of their physician while continuing apremilast treatment from Weeks 16 to 32. We performed a post hoc analysis, assessing apremilast efficacy and safety in Japanese patients stratified by baseline static Physician Global Assessment (sPGA) score (2 [mild] or 3 [moderate]) and special area involvement. Results: Of patients with baseline sPGA = 2 and sPGA = 3, 62.7% and 30.7%, respectively, achieved sPGA score 0 or 1 at Week 32. At Week 32, improvements in skin, nail, scalp, and quality of life assessments were observed regardless of baseline sPGA score. Improvements in these endpoints at Week 32 were also observed in patients with special area (scalp or nail) involvement (n = 134). Incidence of adverse events was similar between patients with baseline sPGA = 2 and sPGA = 3. Conclusions: Apremilast in combination with topical therapy may be a beneficial treatment for Japanese patients, who have limited systemic treatment options for mild to moderate psoriasis or psoriasis in special areas. Trial Registration: NCT03930186. [ABSTRACT FROM AUTHOR]

Objectives: Angico gum (AG) (Anadenanthera colubrina var. Cebil [Griseb.] Altschul) is utilized by some Brazilian communities to alleviate symptoms from gastroesophageal reflux disease. Here, we aimed to investigate the "in vitro" topical protective capacity of AG on human esophageal mucosa. Methods: Biopsies of the distal esophageal mucosa were collected from 35 patients with heartburn (24 non-erosive and 11 with erosive oesophagitis (EE)) and mounted in Üssing chambers. AG was applied topically, followed by exposure with acid solution (pH 2.0 or pH 1.0), where transepithelial electrical resistance (TER) and The transepithelial permeability for fluorescein was assessed. The incubation of the AG labeled with FITC in the esophageal mucosa was localized by fluorescence microscopy. Key findings: Pretreatment with AG prevented the drop in TER induced by acid solution, as well as significantly decreases the fluorescein permeability in non-erosive patients. The protective effect of AG was sustained for up to 120 min both in biopsies of non-erosive and erosive esophagitis. Confocal microscope images showed mucosal luminal adherence of FITC-labeled AG. Conclusion: AG had a prolonged topical protective effect against acid solution in mucosal biopsies of patients with non-erosive and erosive esophagitis. Graphical Abstract [ABSTRACT FROM AUTHOR]

Purpose: Use of mesh is essential in hernia repair. A common complication after hernia repair is surgical site infection (SSI), which poses a risk in spreading to the mesh, possibly causing mesh infection. Topical antimicrobial pretreatment of mesh may potentially reduce SSI risk in hernia repair and has shown promising results in in vitro and in vivo studies. Clinical evidence, however, is more important. This systematic review aims to provide an overview of available clinical evidence for antimicrobial pretreated mesh in hernia repair surgery to reduce SSI. Methods: We report in accordance with PRISMA guidelines. CENTRAL, EMBASE, CINAHL and PubMed were searched up to October 2023 for studies that investigated the use of antimicrobial pretreated mesh on SSI incidence in adults undergoing hernia repair. The primary outcome was SSI incidence. We also collected data on pathogen involvement, hernia recurrence, and mesh infection. A meta-analysis on SSI risk and GRADE-assessment was performed of eligible studies. Results: We identified 11 eligible studies (n = 2660 patients); 5 randomized trials and 6 cohort studies. Investigated interventions included pre-coated mesh, antibiotic carriers, mesh soaked or irrigated with antibiotic or antiseptic solution. Meta-analysis showed no significant reduction in SSI for antibiotic pretreated polypropylene mesh (RR 0.76 [95% CI 0.27; 2.09]; I2 50%). Conclusion: Data on topical mesh pretreatment to reduce SSI risk after hernia repair is limited. Very low certainty evidence from randomized trials in hernia repair surgery shows no significant benefit for antibiotic mesh pretreatment for SSI reduction, but data are imprecise due to optimal information size not being met. [ABSTRACT FROM AUTHOR]

New advancements in nanocarrier technologies are revolutionizing the delivery of drugs through the skin, allowing for precise treatment with better absorption, stability, and bioavailability. This review investigates lipid and inorganic nanocarriers like liposomes, ethosomes, and inorganic nanoparticles and assesses their potential for delivering drugs through the skin. It emphasizes the mechanisms that enable controlled release and deeper skin penetration, which are crucial for ensuring effectiveness in clinical applications. The review synthesizes existing research, acknowledging that only few nanocarriers are successfully deployed in clinical settings. By offering a comprehensive overview, it sheds light on the progress and future obstacles to using nanocarriers for drug delivery through the skin. [ABSTRACT FROM AUTHOR]

The use of nanosized particles is becoming more popular for the topical treatment of skin conditions. In this research work, we created and investigated the effects of solid lipid nanoparticles (SLN) containing hyaluronic acid and tretinoin. Solvent emulsification diffusion method was used to prepare the SLN formulation and characterized for their physicochemical properties. Fourier transform infrared spectroscopy was used to confirm that hyaluronic acid and tretinoin were incorporated in the SLN. Furthermore, X-ray diffractogram, thermal analysis including DSC and TGA and in vitro dissolution, permeation tests were also performed along with microbial assessment. Clinical studies in human were performed to evaluate the effect of the SLN on skin wrinkles. The SLN was 750 ± 31.29 nm in size, with a zeta potential of 13.07 ± 0.75 mV and a narrow polydispersity index of 0.24 ± 0.12. The entrapment efficiency of tretinoin was found to be 90.07 ± 4.79%. Clinical studies in healthy human volunteers demonstrated that 90% of the tested individuals had improved skin conditions (reduction in wrinkles), by at least one grade after 4 weeks of treatment. Regarding the development on SLN, it was found that the internal phase concentration did not considerably affect the physicochemical and microbiological properties. Therefore, Hyaluronic acid has potential for the development of SLN applicable to cosmetic formulations, especially for skin. These findings show that the developed SLN have potential for use as cosmetics in the future.