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Introduction: A better understanding of psoriasis pathogenesis resulted in significant development of new, effective anti-psoriatic therapies, albeit new treatment options, especially topical ones, are still awaited. In vitro studies have shown that cefazolin, the first-generation cephalosporin, has the properties of a specific inhibitor of several pro-inflammatory cytokines. This study aimed to evaluate the effects of cefazolin in 3D human psoriasis skin model and to assess the efficacy and tolerability of topical cefazolin in comparison to topical hydrocortisone butyrate in the treatment of psoriasis. Material and methods: Commercially available 3D human psoriasis skin model was used to evaluate the effect of cefazolin on psoriasis-related gene expression: human β-defensin 2 (HBD2, DEFB-4A), psoriasin (S100A7) and skin-derived peptidase inhibitor 3 (PI3), as well IL-6 and IL-8 secretion. H&E staining was performed to evaluate tissue morphology. The clinical test was an open-label, comparative, left to right study with an active comparator. Ten adult subjects with psoriasis were asked to apply 5% cefazolin emulsion twice daily on the psoriatic plaques located in extensor area of the right elbow, and 0.1% hydrocortisone butyrate ointment on the same body area on the opposite side. The treatment continued for 7 days. The disease severity was assessed according to the modified PASI (mPASI) and Investigator Global Assessment (IGA). Patients were also asked to rate concomitant subjective symptoms, treatment tolerability and global therapeutic effect. Results: Cefazolin down-regulated gene expression of HBD2 (DEFB-4A) and psoriasin (S100A7) and did not affect PI3. In the tested conditions the drug did not reduce IL-6 and IL-8 secretion. Histological evaluation revealed a slight thinning of the epithelium in tissues treated with cefazolin. In patients, both of the treatments resulted in a significant reduction of psoriatic plaques, although the therapeutic effect was significantly better for hydrocortisone butyrate ointment. Both drugs equally significantly reduced pruritus intensity. The treatment with cefazolin was well tolerated and any significant adverse events were observed. Conclusions: Cefazolin can be considered an interesting therapeutic option as a topical immunomodulatory, anti-inflammatory drug, but its anti-psoriatic properties have to be confirmed in well-designed, prospective and vehicle-controlled studies.

A 4 year old boy presented with annular erythema on his nose. The lesion had begun as a small itchy macule seven days earlier. Initially, discoid eczema was diagnosed and he was treated with hydrocortisone butyrate ointment for three days. Although the pruritus improved, the skin rash became more extensive. The patient had no history of preceding injury or insect bite. The household had a cat. On physical examination, an annular erythematous lesion (1 cm ×1 cm) without scaling was observed on the boy’s nose (fig 1). Fig 1 1 cm × 1 cm infiltrated annular erythema without scaling on …

Introduction: Alopecia areata (AA) is a chronic, recurrent, and non-scarring condition resulting in hair loss, which may affect all hair-bearing areas. There are three clinical patterns: patch AA, alopecia totalis, and alopecia universalis. Patients may show spontaneous recovery or respond well to treatment, but the disease may follow a course of relapse. Case Presentation: We report a case of recurrent alopecia totalis following successful treatment six years prior to the current visit. A 19-year-old female of Asian descent was admitted to our clinic due to recurrent hair loss in the last three months. Six years prior, she was diagnosed with alopecia totalis. After four years in remission, she started to have patchy hair loss. Dermatological examination revealed six nummular well-defined alopecia patches all over her parietal, temporal, and occipital scalp. She was treated with triamcinolone injection and light-emitting diode (LED). Additionally, topical minoxidil and hydrocortisone butyrate scalp solution were applied daily. Oral Inosine pranobex was administered twice a week. One year after the first re-administration of the therapy, complete remission was achieved. Conclusions: Relapse in AA is common. Patients should be informed during education and counseling. Long term follow-up is essential in managing patients with AA.

AIMS To quantify the anti-inflammatory potency of topical corticosteroids and topical calcineurin inhibitors by measuring the contact allergic response to a diphenylcyclopropenone (DPCP) challenge in de novo sensitized human volunteers. METHODS Two randomized, double-blind, vehicle-controlled studies were performed encompassing 76 volunteers: 29 in the first and 47 in the second study. Topical drugs were applied pre- and/or post-treatment in block designs. The compounds were tested simultaneously under occluded patch tests covering DPCP-induced dermatitis. Inhibitory responses were assessed by visual scoring and measurements of the oedema thickness with ultrasound. RESULTS When applied both before and after the DPCP challenge, significant anti-inflammatory effects were seen in descending order for tacrolimus 0.1% ointment, clobetasol propionate ointment, betamethasone valerate ointment and hydrocortisone butyrate ointment, while pimecrolimus cream, hydrocortisone ointment and vehicles had no significant effect. Only tacrolimus ointment (P

The aim of this investigation was to develop hydrocortisone butyrate (HB)-loaded poly(d,l-lactic-co-glycolic acid) (PLGA) nanoparticles (NP) with ideal encapsulation efficiency (EE), particle size, and drug loading (DL) under emulsion solvent evaporation technique utilizing various experimental statistical design modules. Experimental designs were used to investigate specific effects of independent variables during preparation of HB-loaded PLGA NP and corresponding responses in optimizing the formulation. Plackett–Burman design for independent variables was first conducted to prescreen various formulation and process variables during the development of NP. Selected primary variables were further optimized by central composite design. This process leads to an optimum formulation with desired EE, particle size, and DL. Contour plots and response surface curves display visual diagrammatic relationships between the experimental responses and input variables. The concentration of PLGA, drug, and polyvinyl alcohol and sonication time were the critical factors influencing the responses analyzed. Optimized formulation showed EE of 90.6%, particle size of 164.3 nm, and DL of 64.35%. This study demonstrates that statistical experimental design methodology can optimize the formulation and process variables to achieve favorable responses for HB-loaded NP.

A novel approach, ultrasonic-thermostatic-assisted cloud point extraction (US-CPE) combined with high-performance liquid chromatography and ultraviolet detection, is developed for the analysis of adrenalines (beclometasone dipropionate, hydrocortisone butyrate and nandrolone phenylpropionate) in milk samples. It is based on the induction of micellar organized medium by using a non-ionic surfactant TMN-6 (polyether-type organic silicon surfactant; structure: (CH3)3C(CH2)8(OC2H4)XOH; average of X = 6) to extract the target adrenalines. In this experiment, phase diagrams were used to study the cavitation and mass transfer behaviors of the two phases on micelles of TMN-6. The main advantages of this system were that it had no ultraviolet absorption and had higher extraction efficiency. In addition, the phase diagram of US-CPE was determined contrast with ultrasonic-thermostatic-cloud point system. The effects of other operating parameters, e.g., concentration of salt and centrifugation time on extraction of US-CPE system, have also been studied in detail.

Introduction: Topical corticosteroids used in various dermatological diseases are available in different potencies and different formulations. The reservoir effect of different potency corticosteroids in the stratum corneum will help the clinicians to choose an appropriate topical steroid to maximize their efficacy and safety as therapeutic agents. Aims: This study was designed to compare the duration of reservoir of different potency topical corticosteroids experimentally in rabbits using histamine-induced wheal suppression test. Materials and Methods: The study was carried out in albino rabbits (as their skin is similar to humans) using four different concentrations of topical steroids, namely mometasone furoate ointment (0.1%), fluticasone propionate ointment (0.005%), betamethasone valerate cream (0.1%), and hydrocortisone butyrate cream (0.1%). These were applied on the back of rabbit on one side and the vehicle was applied on the other. One hour later, histamine-induced wheal suppression test was performed on both sides and wheal area was measured at 10 min for 7 days. Statistical analysis was done by ANOVA followed by post hoc test. Results: Maximum wheal suppression was seen on day 1 (P

Summary Background. Alterations of Toll-like receptors (TLRs) seem to play a role in susceptibility to atopic dermatitis (AD). Aim. To investigate the expression of TLRs in moderate to severe chronic AD in adults before and after a 3-week treatment with 0.1% tacrolimus ointment, compared with 0.1% topical hydrocortisone-17-butyrate. Methods. In total, 21 adult patients with AD were enrolled: 11 were given tacrolimus ointment and 10 were given hydrocortisone butyrate; a further 6 healthy adults formed the control group. The clinical efficacy of the treatment was assessed using the SCORing Atopic Dermatis (SCORAD) index. Biopsies were taken from lesional skin before and after treatment, which were stained immunohistochemically with monoclonal antibodies to TLR-1, -2, -4 and -9. Results. Both 3-week topical treatments improved signs and symptoms in all 21 patients considered, with no significant difference between the two groups. In the skin of patients with AD, TLR-1 was overexpressed and TLR-2 underexpressed compared with healthy controls, whereas no differences were found for TLR-4 and TLR-9. Staining for TLR-1 was decreased in both groups after treatment. AD specimens had higher levels of TLR-2 expression after either treatment compared with baseline, and levels were higher after tacrolimus treatment than after hydrocortisone butyrate. Neither tacrolimus nor hydrocortisone butyrate affected expression of TLR-4 or TLR-9. Conclusion. Short-term therapy with tacrolimus ointment reduced expression of TLR-1, which may inhibit the antimicrobial potential of TLR-2, and also reversed the impairment of TLR-2 in AD lesions. Expression of TLR-4 and TLR-9 was not affected by tacrolimus.

We report the case of a 41-year-old nonatopic women with a previous history of eczematous reaction due to hydrocortisone who suffered worsening of her perennial rhinitis in association with perinasal dermatitis from the use of budesonide in nasal spray form, and stomatitis and pharyngitis due to budesonide in a bronchial inhaler. Patch tests with a series of 25 corticosteroids, some of them at different concentrations and in different vehicles, were positive to tixocortol pivalate, hydrocortisone, budesonide, prednisolone, hydrocortisone butyrate propionate, triamcinolone acetonide, and fluocinolone acetonide. For some of them, a 1% solution in ethanol gave a positive reaction when a 20% mixture in petrolatum did not. Like other authors, we suggest that some multiple positives may represent sensitization to several steroids independently, true cross-reactions, or both, and that ethanol is a better vehicle than petrolatum.

A one-year, randomized, double-blind study was conducted in 80 patients with atopic dermatitis treated with tacrolimus ointment or a corticosteroid regimen (hydrocortisone acetate 1% ointment for head and neck, hydrocortisone butyrate 0.1% ointment for trunk and limbs) to compare efficacy and safety, and effects on Th2-reactivity. The study was completed by 36/40 patients in the tacrolimus group, and 31/40 patients in the corticosteroid group. In both groups affected body surface area, eczema area and severity index, and transepidermal water loss decreased at months 6 and 12. Tacrolimus was superior for all efficacy scores at month 6, and in the head and neck area at month 12. Recall antigen reactivity increased at month 12 in both groups. Adverse events were reported by 40/40 patients in the tacrolimus, and by 34/40 patients in the corticosteroid group. Long-term treatment with topical tacrolimus or a corticosteroid regimen improves atopic dermatitis and recall antigen reactivity, suggesting an improvement in the Th1/Th2-balance. Key words: atopic dermatitis; hydrocortisone butyrate; randomized controlled trial; recall antigen; tacrolimus ointment.

Corticosteroids are currently the first line of treatment for patients with atopic dermatitis. In the pediatric population however, the potential impact of adrenal suppression is always an important safety concern. Twenty boys and girls, 5-12 years of age, with normal adrenal function and a history of atopic dermatitis were maximally treated three times daily with a lipid-rich, moisturizing formulation of hydrocortisone butyrate 0.1% for up to 4 weeks. At the conclusion of the 4-week treatment period, cosyntropin injection stimulation testing showed no evidence of adrenal suppression. In addition, the therapy was noted to be highly efficacious, with a clinical success rate of 80% (Physician Global Score of (0) clear or (1) almost clear). No local side effects associated with prolonged use of topical corticosteroids were reported. In summary, this study supports the contention that this lipid-rich, moisturizing formulation of hydrocortisone butyrate 0.1% was a well-tolerated and beneficial treatment for atopic dermatitis, demonstrating no adrenal suppression in the pediatric population aged 5-12 years. The relevance of these findings for children below 5 years of age, because of difference in body mass/surface area ratios, remains to be determined.

Summary Background While many studies have demonstrated the efficacy and safety of tacrolimus ointment in the treatment of atopic dermatitis (AD), only a few have investigated the effects of tacrolimus on inflammatory cells and their cytokine gene expression in patients with AD. Objectives To characterize further the immunophenotype of infiltrating cells and the production of certain cytokines before and after treatment with topical tacrolimus and hydrocortisone butyrate. Methods Nine adult patients with moderate to severe AD were treated with tacrolimus ointment, while seven control patients were treated with hydrocortisone butyrate ointment. We performed lesional skin biopsies before and after treatment. These were stained immunohistochemically with a panel of monoclonal antibodies including those to CD1a, CD3, CD4, CD8, myeloperoxidase, EG1, EG2, tryptase, interferon-γ, interleukin (IL)-4, IL-5, IL-12, IL-13, receptors for CXC chemokines (CXCR) 3 and 4, and receptor 3 for CC chemokines. Results CD3+, CD4+ and CD8+ lymphocytes, and eosinophil and neutrophil granulocytes were significantly reduced in post-treatment tacrolimus specimens, while CD1a+ cells and mast cells were not. The expression of cytokines and chemokine receptors tested, except for CXCR3, was diminished by tacrolimus treatment. Moreover, tacrolimus produced a greater reduction of lymphocytes, eosinophils and most cytokines than that induced by hydrocortisone butyrate. Conclusions Tacrolimus not only inhibits T-lymphocyte proliferation and cytokine production, but also plays an important role in the IL-12-induced shift from a T-helper (Th) 2 to a Th1 cytokine profile that characterizes the development of chronic AD. Tacrolimus also demonstrates wider pharmacodynamic effects than hydrocortisone.

This study was conducted to develop formulations of hydrocortisone butyrate (HB)-loaded poly(d,l-lactic-co-glycolic acid) nanoparticles (PLGA NP) suspended in thermosensitive gel to improve ocular bioavailability of HB for the treatment of bacterial corneal keratitis. PLGA NP with different surfactants such as polyvinyl alcohol (PVA), pluronic F-108, and chitosan were prepared using oil-in-water (O/W) emulsion evaporation technique. NP were characterized with respect to particle size, entrapment efficiency, polydispersity, drug loading, surface morphology, zeta potential, and crystallinity. In vitro release of HB from NP showed a biphasic release pattern with an initial burst phase followed by a sustained phase. Such burst effect was completely eliminated when nanoparticles were suspended in thermosensitive gels and zero-order release kinetics was observed. In HCEC cell line, chitosan-emulsified NP showed the highest cellular uptake efficiency over PVA- and pluronic-emulsified NP (59.09 ± 6.21%, 55.74 ± 6.26%, and 62.54 ± 3.30%, respectively) after 4 h. However, chitosan-emulsified NP indicated significant cytotoxicity of 200 and 500 μg/mL after 48 h, while PVA- and pluronic-emulsified NP exhibited no significant cytotoxicity. PLGA NP dispersed in thermosensitive gels can be considered as a promising drug delivery system for the treatment of anterior eye diseases.

SUMMARY In a double blind trial 0·1% hydrocortisone butyrate cream gave after a week a significantly better therapeutic response in eczema than 0·1% triamcinolone acetonide (P

Summary Background Staphylococcus aureus has a peculiar ability to colonize the skin of patients with eczema and atopic dermatitis (AD), and is consistently found in eczematous skin lesions in these patients. A correlation between the severity of the eczema and colonization with S. aureus has been demonstrated, and it has been determined that bacterial colonization is an important factor aggravating skin lesions. Patients colonized with S. aureus have been treated with antibiotics in several open and double-blind placebo-controlled studies, with conflicting results. Objectives To investigate the colonizing features of S. aureus in the lesional and nonlesional skin of patients with eczema and AD in China and to compare the therapeutic effect of mupirocin plus hydrocortisone butyrate with vehicle ointment plus hydrocortisone butyrate. Methods A multicentre, double-blind randomized trial was conducted. Eczema Area and Severity Index (EASI) scores were evaluated before the start of the trial and on the 7th, 14th and 28th day of treatment. Swabs for bacterial isolation were taken from lesional skin before the start of the trial and on the 7th, 14th and 28th day of treatment, and from nonlesional skin only before the start of the trial. A combination topical therapy with mupirocin plus hydrocortisone butyrate ointment was used in the experimental group, with vehicle ointment plus hydrocortisone butyrate ointment as a control. Results Of 327 patients enrolled in the study, 208 had eczema and 119 had AD. Bacteria were isolated from 70·2% of lesional and 32·7% of nonlesional skin samples from patients with eczema, of which S. aureus accounted for 47·3% and 27·9%, respectively. Bacteria were isolated from 74·8% of lesional and 34·5% of nonlesional skin samples from patients with AD, of which S. aureus accounted for 79·8% and 80·5%, respectively. The colonization density of S. aureus was markedly higher in lesional than in nonlesional skin, both in patients with eczema and with AD (P 0·05). However, in patients with eczema with a clinical score of > 8 or in patients with AD with a clinical score of > 7, the therapeutic effect in the experimental groups was superior to that in the control groups (P 0·05). Following the improvement of symptoms and signs of eczema and AD, the positive rates of bacteria and S. aureus were reduced on the 7th day of treatment. Conclusions This study confirmed that lesional skin of patients with eczema and AD was more frequently colonized with S. aureus than was nonlesional skin. The more severe the eczema, the higher the colonization rate of S. aureus, and S. aureus was also more often present in lesional and nonlesional skin in patients with AD than in those with eczema. Staphylococcus aureus infection is related to the pathogenesis of eczema and AD. An antibiotic–corticosteroid combination and corticosteroid alone both gave good therapeutic effect in eczema and in AD, and both reduced colonization by S. aureus. Early combined topical therapy is beneficial to patients with moderate to severe eczema and AD, and it is unnecessary to use antibiotics at later stages of disease or in mild eczema or AD.

Summary Background Atopic dermatis (AD) is a chronic disease that often requires long-term treatment. Topical corticosteroids are the usual therapy for patients with AD, but prolonged usage can result in skin atrophy and other side-effects. Objectives In a randomized, double-blind, comparative study, to compare the efficacy and safety of a 6-month treatment period with 0·1% tacrolimus ointment vs. a corticosteroid ointment regimen in adults with moderate to severe AD. Methods Treatment was applied twice daily for a maximum of 6 months. Patients in the tacrolimus treatment group (n = 487) applied 0·1% tacrolimus ointment to all affected areas over the whole body. The patients treated with the corticosteroid regimen (n = 485) applied 0·1% hydrocortisone butyrate ointment to affected areas on the trunk and extremities and 1% hydrocortisone acetate ointment to affected areas on the face and neck. The study primary endpoint was the response rate, i.e. the proportion of patients with at least 60% improvement in the modified Eczema Area and Severity Index (mEASI) between baseline and month 3. Results By month 3, more patients in the 0·1% tacrolimus group responded to treatment (72·6% vs. 52·3% in the corticosteroid group, P

Zusammenfassung Hintergrund: Topische Glukokortikoide sind Mittel der ersten Wahl zur Behandlung zahlreicher entzundlicher und hyperproliferativer Hauterkrankungen. Der Vasokonstriktionstest eignet sich zur Bestimmung der Wirkstarke von Kortikoiden. Patienten und Methode: In die vorliegenden Studie wurden insgesamt 60 hautgesunde Probanden eingeschlossen. Drei Kortikoide und eine korrespondierende wirkstofffreie Grundlage wurden auf Basis von Creme- und Salben-Zubereitungen in einer doppelblinden, randomisierten, intra-individuellen klinischen Studie an hautgesunden Probanden mittels Vasokonstriktionstest untersucht. Es wurden die Wirkstarken von Hydrocortison, Hydrocortison-17-butyrat und Mometasonfuroat sowie Hydrocortison-17-butyrat und Placebo im Vergleich bestimmt. Ergebnisse: Die Summenscores der klinischen Beurteilung betrugen fur Hydrocortison 34 (Creme) und 18 (Salbe), fur Hydrocortisonbutyrat 47 (Creme) und 55 (Salbe) und fur Mometasonfuroat 57 (Creme) und 50 (Salbe). Der in der Chromametrie bestimmte Abblaseffekt betrug fur Hydrocortison 1,73 (Creme) und 1,48 (Salbe), fur Hydrocortisonbutyrat 2,87 (Creme) und 3,26 (Salbe) und fur Mometasonfuroat 2,98 (Creme) und 2,84 (Salbe). Schlusfolgerungen: Bei der klinischen und chromametrischen Beurteilung der Vasokonstriktion wurde eine Wirksamkeit aller Verumzubereitungen gezeigt, wobei sich Hydrocortisonbutyrat als uberlegen gegenuber Hydrocortison erwies. Summary Background: Topical corticosteroids are the treatment of choice for numerous inflammatory or hyperproliferative skin diseases. The vasoconstriction assay is suitable to determinate corticosteroid activity. Patients and methods: 60 healthy volunteers were studied. Three corticosteroids in both cream and ointment bases, as well as one corresponding vehicle, were investigated in a double-blind, randomised, intra-individual clinical study, using a vasoconstriction assay. The potencies of hydrocortisone, hydrocortisone-17-butyrate and mometasone furoate were measured, while hydrocortisone-17-butyrate was also compared to the vehicle. Results: The sum score of the clinical evaluation was for Hydrocortisone 34 (cream) and 18 (ointment), for Hydrocortisone butyrate 47 (cream) and 55 (ointment) and for Mometasone furoate 57 (cream) and 50 (ointment). The chromametric values for blanching with hydrocortisone were 1.73 (cream) and 1.48 (ointment), hydrocortisone butyrate 2.87 (cream) and 3.26 (ointment) and mometasone furoate 2.98 (cream) and 2.84 (ointment). Conclusions: The clinical and chromametric evaluation of vasoconstriction showed activity for all corticosteroid formulations. Hydrocortisone butyrate was shown to be superior to hydrocortisone.

Two multicentre, randomised, parallel group, double-blind, comparative studies in children (2-14 yr) evaluated fluticasone propionate (FP) 0.05% cream for both acute and maintenance treatment of moderate to severe atopic dermatitis (AD).One study compared FP with hydrocortisone (HC) 1% cream (FP 70, HC 67) and the other with hydrocortisone butyrate (HCB) 0.1% cream (FP 67, HCB 62). Treatments were applied twice daily, for 2-4 weeks until the AD was stabilised, and thereafter intermittently ('as required') for up to 12 weeks.The primary outcome measure, Total AD Score, recorded at the end of the acute and maintenance phases, was significantly lower (indicating improvements in disease severity) following treatment with FP compared with either HC or HCB (acute phase difference vs. HC, -2.39, 95%CI -3.47, -1.31; p0.001 and vs. HCB, -1.25, 95%CI -2.46, -0.05; p=0.042) and (maintenance phase difference vs. HC, -1.88, 95%CI -3.20, -0.56; p=0.006 and vs. HCB, -1.39, 95%CI -2.72, -0.05; p=0.042). In both studies treatments were equally well tolerated with no visible signs of skin atrophy.In both the acute and longer term management of AD in children, FP demonstrated a high level of efficacy and maintenance of disease control with a tolerability similar to HC 1%, a lower potency corticosteroid.

This study examines reproducibility of water and ethanol drop volumes from plastic squeeze dropper bottles, examines the difference in drop volumes between commonly used liquid patch test solutions, and evaluates the volumes of water and ethanol needed to saturate Finn and IQ Chamber filter papers. 2 plastic squeeze dropper bottles recommended for use in patch testing have poor reproducibility compared to other bottles tested. 3 aqueous allergens tested (formaldehyde 1%, methylchloroisothiazolinone/methylisothiazolinone 0.01%, and dimethylol dihydroxyethyleneurea 4.5%) have drop volumes equivalent to water. Smaller drop volumes are produced by ethanol, hydrocortisone butyrate 1% in ethanol, cocamidopropyl betaine 1% a.q., and propylene glycol 30% a.q. Filter paper saturation volumes using distilled water are 16-19 micro L in standard Finn Chambers and 29-35 micro L in IQ Chambers. Ethanol saturation volumes are slightly lower. Previously recommended volumes of application for aqueous allergens of 15 micro L for standard Finn Chambers and 25 micro L for IQ Chambers (slightly below the filter paper saturation points) are appropriate. Selection of dropper bottles should consider drop volume reproducibility, differing drop volumes for different allergens, and the patch test chamber system being used.

SummaryBackground Most studies investigating steroid allergy have been performed with tixocortol pivalate, hydrocortisone butyrate and budesonide. Betnovate® and Dermovate® are widely prescribed in the U.K. but little is known about the frequency of sensitization to them. Objectives To determine the optimum method to detect contact allergy to betamethasone valerate (BV) and clobetasol propionate (CP). Methods Seven centres tested consecutive patients attending for investigation of suspected allergic contact dermatitis to these steroids at a range of concentrations in different vehicles. Results Of 1562 patients tested, 16 (1%) reacted to either BV or CP. Ten patients (0·7%) reacted to BV and 13 (0·8%) to CP. Two patients of a further centre were included in analysis of dilutions and vehicles. Sixteen of a total of 25 reactions (64%) were identified with a 1% dilution in ethanol. Conclusions Consideration should be given to adding BV and CP to a standard allergy series, given that both are frequently used in the treatment of eczema and that most patients sensitized to them are not identified with currently used markers of steroid allergy. If patch tests to BV and CP are initially negative, but an allergy is suspected, the patient should be further investigated. Further studies are required to identify the ideal patch test material.

Background: Vehicle-controlled studies have demonstrated the efficacy and safety of tacrolimus ointment for patients with atopic dermatitis. Objective: This study was undertaken to compare 0.03% and 0.1% tacrolimus ointment with 0.1% hydrocortisone-17-butyrate ointment, a midpotent to potent topical corticosteroid, in the treatment of adult patients with moderate-to-severe atopic dermatitis. Methods: Patients applied ointment twice daily to all affected areas for 3 weeks in this multicenter, randomized, double-blind, parallel-group study. The primary endpoint was the modified eczema area and severity index (mEASI) mean area under the curve as a percentage of baseline. Results: Five hundred seventy patients were randomized and received treatment. Discontinuations included 22 of 193 patients from the 0.03% tacrolimus group, 22 of 191 patients from the 0.1% tacrolimus group, and 17 of 186 patients from the hydrocortisone butyrate group. The median mEASI mean area under the curve as a percentage of baseline was 47.0%, 36.5%, and 36.1% for patients who received 0.03% tacrolimus, 0.1% tacrolimus, and 0.1% hydrocortisone butyrate, respectively. There was no statistically significant difference between 0.1% tacrolimus and 0.1% hydrocortisone butyrate; however, the lower improvement in mEASI for 0.03% tacrolimus was statistically significant when compared with 0.1% tacrolimus ( P P = .002). Skin burning and pruritus at the application site showed a higher incidence in the tacrolimus treatment groups than in the hydrocortisone butyrate group ( P Conclusions: The efficacy of 0.1% tacrolimus ointment was similar to that of 0.1% hydrocortisone butyrate ointment and was lower for 0.03% tacrolimus ointment. No serious safety concerns were identified. (J Allergy Clin Immunol 2002;109:547-55.)

A valid approach to treating frontal fibrosing alopecia (FFA), a scarring alopecia, does not yet exist. The aim of this study is to evaluate the efficacy of a topical application composed of minoxidil, hydrocortisone butyrate, 17α-estradiol, ciclosilicone pentamer, and alcohol in women affected by FFA. Forty women affected by FFA were treated with 2 ml of a topical lotion composed of 2% minoxidil base, 0.08% hydrocortisone butyrate, 0.05% 17α-estradiol, 16% ciclosilicone pentamer, 96° alcohol, applied once a day on the scalp. A score index, based on the comparison of the photos, taken at the beginning (T0) and after 36 months (T36), was used. The topical lotion led to an improvement in 20 patients, stabilization in 15 patients and worsening of the clinical condition in 5 women. This topical lotion induces a considerable improvement or stabilization of frontal fibrosing alopecia.

Melasma is a common melanosis often difficult to treat.The aim of this paper was to report on the safety and efficacy of non-ablative fractional photothermolysis combined with the use of triple-combination cream (TCC) on a large population with melasma resistant (i.e., with no complete/near-complete clearing) to TCC alone.Seventy-six patients with resistant melasma underwent a combined treatment protocol. The protocol consisted of a TCC (hydroquinone 4%, retinoic acid 0.03%, hydrocortisone butyrate 0.1%) applied daily for 10 days followed by four laser treatments performed in 3-week intervals with a fractional 1540-nm erbium-glass laser. During these intervals, and for 3 months after the last laser session, TCC was also applied daily following a "pulse-therapy" scheme. Improvement was assessed by the melasma-area-and-severity-index (MASI) score.At 1 month, marked (75%) and moderate (51-75%) clearing of melasma were observed in 46 of 76 (67.1%) and 12 of 76 (21%) cases, respectively. At 6 months, we noticed a marked improvement in 16 of 76 (21.1%) and no improvement in 33 of 76 (43.4%) patients.Our study proposes the combination of NFP/TCC as a useful therapy for patients with melasma resistant to TCC alone, but it shows that its long-term efficacy is limited.

Background Topical medications are often the first line therapy utilized by dermatologists for a variety of conditions. However, a common side effect of topical medications is application site irritation. The aim of this study was to evaluate and compare the sensory irritation caused by hydrocortisone butyrate lipocream 0.1% using a non-invasive and inexpensive technique. Methods Twenty participants with corticosteroid-responsive dermatoses were enrolled. Three target areas of unaffected skin were abraded. A negative control (petrolatum ointment), a positive control (an over-the-counter [OTC] anti-itch preparation containing benzyl alcohol), and a test product (hydrocortisone butyrate lipocream 0.1%) were each applied to separate target areas on the legs. Participants rated the irritation of each target area using a 10-point scale (1 [no symptoms] to 10 [intolerable burning/ stinging requiring removal of the medication]). Results The mean irritation scores for petrolatum ointment, the OTC anti-itch preparation, and hydrocortisone butyrate lipocream 0.1% were 1.30, 5.70, and 1.95, respectively. The difference in irritation between the OTC anti-itch preparation and hydrocortisone butyrate lipocream 0.1% was highly significant (P

Background Seborrheic dermatitis is a corticosteroid-responsive condition. Topical corticosteroids exhibit distinct activities according to the type and cellular site of action of the hormone and its vehicle. The latter influences not only drug penetration, but also the structure and function of the horny layer. Objective The present study compared the early response of seborrheic dermatitis to two topical corticosteroids using objective quantifications of the stratum corneum alterations. Method Squamometry was used to supplement the clinical assessment of the therapeutic activity of 0.1% hydrocortisone butyrate in an oil-in-water emulsion (Locoid Crelo®) and 0.05% betamethasone 17–21 dipropionate lotion (Diprosone® lotion). Results The hydrocortisone butyrate formulation had a faster onset of efficacy as documented by a greater improvement of lesions after a 1-week twice-daily treatment. Clearance or marked improvement was observed in the two treatment groups at completion of the 2-week trial. Conclusions As the ranking of the clinical efficacy was not predicted by the intrinsic anti-inflammatory potency of the steroids, it is suggested that the vehicle contributed itself to the global in vivo efficacy. The anti-inflammatory action of hydrocortisone butyrate appears to be synergistically implemented by the emollient effect of the specially designed oil-in-water emulsion.

Background: Chronic actinic dermatitis represents a spectrum of photosensitive dermatoses. Phototesting and photopatch testing are necessary to elucidate the specific subtype. Such patients may have multiple cutaneous allergies and photoallergies. Objective: This is a case report of a patient with chronic actinic dermatitis whose condition was worsened by certain sunscreens and corticosteroids. Our purpose was to identify the specific subtype of chronic actinic dermatitis and cutaneous allergens. Methods: Phototesting to UVB and UVA was performed. Photopatch testings to standard photoallergens and to Photoplex sunscreen ingredients was performed. Patch testing to standard allergens and proprietary corticosteroids was performed. Results: Positive photoallergies to Photoplex sunscreen and the UVA screen within Photoplex, Parsol 1789 (4-tert-butyl-4′-methoxydibenzoyl-methane), were identified. Positive allergies to Aclovate (alclometasone dipropionate) cream and ointment and Locoid (hydrocortisone butyrate) ointment were identified. The patient showed increased UVB sensitivity. Conclusion: This is a case report of a patient with chronic actinic dermatitis. A relevant photoallergy to Parsol 1789 and corticosteroid sensitivities to aclometasone and hydrocortisone butyrate were identified. Multiple cutaneous allergens may be identified in patients with chronic actinic dermatoses, and avoidance of known allergens may result in significant improvement of the chronic dermatitis.

Twice daily application of Locoid Lipocream fatty cream (0.1% hydrocortisone 17-butyrate) was compared with Locoid Lipocream once daily and Locobase once daily in a randomized double-blind study of 150 atopic eczema patients (75 in each study group) recruited from one centre in each of Denmark, Norway, Finland and The Netherlands. A five-point rating scale was used at the beginning of the study and 2 and 4 weeks after the start of treatment to score erythema, induration, scaling, pruritus, excoriation and overall severity. At the end of the treatment both the investigators' and the patients' opinions on the overall improvement in the skin lesions were scored. Both treatments significantly reduced all clinical features equally, but the clearance rate was significantly higher with the twice daily regimen. Subjectively, both investigators and patients preferred the twice daily regimen. Adverse events occurred in eight patients, four in each treatment group, but in only one case did the treatment have to be s...

Inclusion complexation of hydrocortisone butyrate (HB) with α-, β-, γ- and dimethyl-β-cyclodextrins (DM-β-CyD) in aqueous solution and in solid state was investigated to examine and compare the interactions of CyDs with HB, which is practically insoluble in water, and to improve solubility and dissolution rate. Complex formation of HB with CyDs in aqueous solution was studied by solubility analysis, circular dichroism, ultraviolet absorption and 1 H-NMR spectroscopy. In the study of solid state interaction of HB with CyDs, equimolar HB-CyD solid complexes were prepared by the solvent evaporation method and complexation was assessed by infrared spectroscopy and thermal analysis. To elucidate the inclusion complexation, the stoichiometric ratio, which was found to be 1:1, apparent stability constants and thermodynamic parameters for HB-CyD systems were determined. The solubility increase of HB in the presence of CyDs in water was in the rank order of DM-β-CyD > γ-CyD > β-CyD > α-CyD. The spectroscopic data suggested a different inclusion mode of HB within various CyD cavities. The dissolution rate of DM-β-CyD solid complex was extremely rapid compared with those of α-, β- and γ-CyD solid complexes.

35歳女子の顔面にみられたロコイド®(酪酸ハイドロコーチゾン)軟膏による接触皮膚炎の1例を報告した。貼布試験による確認後, 一連の市販副腎皮質ステロイド外用剤による貼布試験を施行し, 酪酸プロピオン酸ハイドロコーチゾン, ブデゾニドにも陽性の所見をえた。前者についてはC17位を中心とする立体構造が抗原決定基となった可能性を考えた。

Advantan* is a new potent corticoid preparation that has been specially developed for the local treatment of eczematous dermatoses. The active ingredient of Advantan is methylprednisolone aceponate (MPA), a nonhalogenated corticoid diester. Advantan has been developed in three different formulations (cream, ointment, fatty ointment). Pharmacological studies have shown that the potency of MPA in the skin after dermal application is almost equivalent to that of Cvalerate and clobetasol propionate, and exceeds that of hydrocortisone butyrate. The toxicological programme provided no grounds for doubting the safety of products containing MPA, when used as directed. Like all other corticoids, MPA exerts its action via an intracellular receptor but its pharmacokinetic properties differ from those of other corticoids in that it leads to a high degree of dissociation between topical and systemic action. As a result of the two-fold esterification, MPA is highly lipophilic. Thus, it penetrates readily into the skin ...

BACKGROUND: Corticosteroids may cause immediate or delayed hypersensitivity. In 1989, based on structural and clinical characteristics, we put forward a classification of corticosteroids into four cross-reacting groups, namely group A, B, C, and D, the latter later subdivided into two subgroups, i.e. D1 and D2. The constituents on the D-ring of the corticosteroid-molecule are considered to have a central role for binding to skin proteins and for cross-reactions patterns; however, halogenation of the molecules is also interfering. OBJECTIVE: To study the clinical data and analyse simultaneous positive reactions obtained in a large group of corticosteroid-allergic patients. METHODS: Patch tests were performed with the baseline series, to which hydrocortisone butyrate and prednisolone caproate were added, as well as with the corticosteroids to which the patients had been exposed. Three hundred and forty subjects with a presumed or proven corticosteroid allergy were further investigated with an extended series containing 72 molecules. RESULTS: Out of 11 596 patients investigated, 315 subjects reacted positively to at least 1 corticosteroid-molecule, with most of them presenting with multiple positive reactions. CONCLUSION: A prevalence of corticosteroid allergy of 2.7% was found. Despite validity of the ABCD (sub)classification in many cases, possible adjustments may have to be considered.

Topical tacrolimus represents an effective and well-tolerated treatment for atopic dermatitis (AD). Its known effects include reduced production of proinflammatory cytokines and reduced chemokine gradient. We performed lesional skin biopsies on adult patients affected by moderate-to-severe AD. Then, patients were randomized to receive local treatment with tacrolimus ointment 0.1% and hydrocortisone butyrate ointment 1%. On the 21st day of treatment, another skin specimen was taken. Nine patients treated with tacrolimus and seven treated with hydrocortisone successfully concluded the trial. By immunohistochemistry (alkaline phosphatase/antialkaline phosphatase method), we demonstrated that endothelial leucocyte adhesion molecule (ELAM)-1, vascular cell adhesion molecule (VCAM)-1 and intercellular adhesion molecule (ICAM)-1 showed different intensities and patterns of expression in untreated AD lesions. Tacrolimus-treated specimens featured a significant reduction of the expression of ELAM-1, VCAM-1 and ICAM-1, while hydrocortisone-treated lesions did not. Inhibition of adhesion molecule expression may represent another selective mechanism of action of topical tacrolimus in AD.

Background: Concern exists that the prolonged application of immunomodulators to treat atopic dermatitis may cause systemic immunosuppression. Aims: In a 7-month, multicentre, randomised, controlled trial, we investigated the equivalence of response to vaccination against meningococcal serogroup C disease with a protein-conjugate vaccine in children (2–11 years) with moderate to severe atopic dermatitis, by applying either 0.03% tacrolimus ointment (TAC-O; n = 21) or a hydrocortisone ointment regimen (HC-O; n = 111). Methods: TAC-O was applied twice daily (bid) for 3 weeks, and thereafter daily until clearance. 1% hydrocortisone acetate (HA) for head/neck and 0.1% hydrocortisone butyrate ointment for trunk/limbs was applied bid for 2 weeks; thereafter HA was applied bid to all affected areas. At week 1, patients were vaccinated with protein-conjugate vaccine against meningococcal serogroup C, and challenged at month 6 with low dose meningococcal polysaccharide vaccine. The control group (44 non-atopic dermatatits children) received the primary vaccination and challenge dose. Assessments were made at baseline, weeks 1 and 5, and months 6 and 7. The primary end point was the percentage of patients with a serum bactericidal antibody (SBA) titre ⩾8 at the week 5 visit. Results: The response rate (patients with SBA titre ⩾8) was 97.5% (confidence interval (CI) approximately 97.3 to 100), 99.1% (94.8 to 100) and 97.7% (93.3 to 100) in the TAC-O, HC-O and control groups, respectively. Conclusions: The immune response to vaccination against meningococcal serogroup C in children with atopic dermatitis applying either 0.03% TAC-O or HC is equivalent. Ointment application does not affect the immediate response to vaccination, generation of immune memory or humoral and cell-mediated immunity.

Tacrolimus ointment (Protopic) is a topically applied macrolide lactone immunomodulator effective in the treatment of atopic dermatitis. Its mechanism of action primarily involves calcineurin inhibition, which interrupts cytokine gene expression and leads to the downregulation of T-cell activity. Tacrolimus ointment (0.03% and 0.1% for adults and 0.03% for children) is an effective treatment for atopic dermatitis of the trunk and limbs, as well as sensitive skin areas such as the face. Its efficacy is similar to or greater than that of hydrocortisone acetate 1%, hydrocortisone butyrate 0.1% and betamethsone valerate 0.12% ointments and pimecrolimus 1% cream. Systemic absorption of tacrolimus from the ointment is minimal, and adverse events, which are mostly associated with the application site and include skin burning and pruritus, tend to resolve early in treatment. Unlike topical corticosteroids, tacrolimus ointment is not associated with skin atrophy, and it is a well tolerated treatment for adults or children with atopic dermatitis, particularly when long-term treatment is indicated or the face or skin-fold regions are involved.

Background There is clinical uncertainty concerning the effectiveness of the new topical immunomodulators vs. the conventional use of topical steroids for the treatment of atopic dermatitis. Objectives To assess patient satisfaction with these two prescription topical remedies for atopic eczema. Methods In an open-label, 2-week, comparative study, 10 patients demonstrating atopiform dermatitis were given tacrolimus and 0.1% hydrocortisone butyrate in a 70% oil-in-water base to apply to the eczema on opposite sides of the body. After 2 weeks of applying the agents twice daily to their respective sides of the body surface, the study subjects completed a 12-question survey to assess their opinions of the two products. Results There was a preference for the nonfluorinated topical steroid over tacrolimus in this cursory head-to-head study. There were no withdrawals from the study or side-effects reported with either product. Conclusions Trials of short duration with small numbers of patients do not adequately inform practitioners regarding the use of these topical remedies. However, the higher satisfaction of patients with 0.1% hydrocortisone buyrate in a 70% oil-in-water base over tacrolimus certainly warrants further investigation.

SummaryBackground Fexofenadine, a nonsedating, H1-receptor selective antihistamine, exhibits consistent efficacy and safety in the treatment of allergic rhinitis and urticaria. The pruritus associated with atopic dermatitis is considered to be induced, in part, by histamine. Therefore, we thought that fexofenadine may be useful in the relief of pruritus associated with atopic dermatitis. Objective To compare the efficacy of twice-daily fexofenadine hydrochloride (HCl) 60 mg vs. placebo in reducing the pruritus associated with atopic dermatitis. Methods In this randomized, multicentre, double-blind, placebo-controlled study, patients (aged ≥ 16 years) with atopic dermatitis underwent a 1-week placebo lead-in period, followed by randomization to fexofenadine HCl 60 mg twice daily or placebo for 1 week. All patients also received topical treatment with 0·1% hydrocortisone butyrate twice daily throughout the study. The primary efficacy endpoint was mean change in pruritus score from baseline. Patients reflectively recorded pruritus scores twice daily (day and night) using a five-point scale (0 = none; 4 = very severe). Results Fexofenadine (n = 201) significantly decreased the severity of pruritus compared with placebo (n = 199) (mean change in score −0·75 (unadjusted 95% confidence interval [−0·88, −0·62]) vs. −0·5 [−0·62, −0·38], respectively; P = 0·0005). This improvement was seen after just 1 day of treatment (P = 0·039) and was maintained throughout the treatment period (P = 0·019). Compared with placebo, fexofenadine significantly improved both diurnal (P = 0·0001) and nocturnal pruritus (P = 0·013). In addition, significantly more patients in the fexofenadine group experienced a reduction in the ratio of pruritus area to body surface area compared with those in the placebo group (P = 0·007). The incidence of adverse events was low and similar across all treatment groups. Conclusions Fexofenadine HCl 60 mg twice daily demonstrated a rapid, significant improvement in the pruritus associated with atopic dermatitis, with a safety profile equivalent to that of placebo.

Topical steroid creams and ointments have been available as over-the-counter (OTC) medications for the self treatment of acute dermatitis and other steroid responsive skin disorders for more than ten years. Despite earlier fears, widespread availability and use of these creams is not associated with clinically significant adverse effects. In dermatological practice, hydrocortisone 1% remains the mainstay of treatment for facial eczema, but it is often not effective in eczema affecting other body areas. Eumovate(TM) (clobetasone butyrate 0.05%) cream has recently been made available as a pharmacy medication for the short-term management of acute eczema and allergic dermatitis by adults and children aged 10 or older, based on evidence derived from clinical trials involving over 3500 patients. This review summarises the key efficacy and safety data derived from 29 clinical trials and the post-licensing pharmacovigilance safety information, which supported the reclassification of this product for OTC use. These data show clobetasone butyrate 0.05% is more effective than 1.0% hydrocortisone in the treatment of eczema and more effective than flurandrenolone 0.0125% (p=0.01%) and a potent topical steroid hydrocortisone butyrate (p

Background We report a case of erysipelas in a non-small-cell lung cancer patient who was receiving gefitinib. The patient was a 94-year-old woman with stage IV non-small-cell lung cancer (adenocarcinoma) who had been diagnosed by histological examination of a transbronchial lung biopsy specimen. The gene mutation status of the epidermal growth factor (EGFR) was positive. She received gefitinib (250 mg orally once daily) as first-line chemotherapy starting September 14. On October 6, she presented with a 3-week history of acneiform rash and squamae around the nose and fingers. The skin complication resolved in response to topical steroid therapy with 0.1% hydrocortisone butyrate for the nose area and 0.05% b-methasone butyrate propionate for the fingers. Nine days later, she was referred for dermatologic consultation to evaluate erythematous swelling that had appeared 3 days earlier on the face. Her body temperature was 37.1°, and serum C-reactive protein levels were high. She was diagnosed with erysipelas induced by gefitinib, and gefitinib treatment was stopped. The erythematous swellings on the face responded well to systemic antibiotic therapy (intravenous administration of 1 g cefazolin sodium twice daily for 7 days). We believe that this is the first reported case of erysipelas induced by gefitinib.