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Despite its high global prevalence, molluscum contagiosum (MC) is not well understood outside of dermatology. Due to the potential self-limiting nature of MC, a common clinical approach in management is to wait for the papules to resolve spontaneously over several weeks to months, without medical intervention. However, this "watch and wait" approach increases risk of spreading the virus to others, extending the duration of the infection, and emergence of several psychosocial issues (e.g., anxiety, embarrassment, isolation). Molluscum contagiosum can be particularly challenging to treat in immunocompromised patients (e.g., human immunodefficiency virus [HIV], organ transplant recipients). This article reviews diagnostic characteristics and treatment options for MC, as well as associated risk factors and comorbidities. Treatment of immunocompromised individuals, in whom the risks of diffuse MC with persistence and spread are relatively high, is emphasized. The authors highlight the importance of actively treating the MC papules, as opposed to letting the virus "run its course" with no active intervention, with the goals of reducing the risk of spreading infection to others, shortening the duration of infection, and decreasing adverse psychosocial sequelae commonly associated with MC. [ABSTRACT FROM AUTHOR]

Molluscum contagiosum (MC) is a viral infection that affects primarily pediatric patients, sexually active young adults, and immunocompromised people of all ages. MC occurs all over the world, making up about one percent of skin disorders and appears to be increasing in prevalence. This cutaneous infection is often associated with atopic dermatitis and is typically self-limiting, although spontaneous resolution can take months to years. Many treatments exist, but only one--a drug-device product using topical cantharidin-- is approved by the United States (US) Food and Drug Administration (FDA) for treatment of MC. For many years, there was a lack of an established or FDA-approved first-line treatment for MC, which might have contributed to the common "benign neglect" attitude of physicians regarding treatment of MC. Unfortunately, this noninterventional approach can increase risk of spreading infection and result in longer duration of infection, physical discomfort, and psychosocial issues due to persistence of the MC lesions. This article reviews available epidemiology data and explores treatment options and therapeutic gaps in MC management. [ABSTRACT FROM AUTHOR]

OBJECTIVE: A new formulation of benzoyl peroxide (E-BPO cream, 5%) entraps benzoyl peroxide (BPO) in silica microcapsules. This study assesses the efficacy, safety, and tolerability of E-BPO cream, 5%, in rosacea in two Phase III clinical trials. METHODS: In two 12-week, randomized, double- blind, vehicle cream-controlled Phase III trials, 733 subjects at least 18 years old with moderate to severe rosacea were randomized (2:1) to once-daily E-BPO cream, 5%, or vehicle. RESULTS: In Study 1, the proportion of subjects achieving IGA clear/almost clear at Week 12 was 43.5 percent for E-BPO cream, 5%, and 16.1 percent for vehicle. In Study 2, the respective values were 50.1 percent and 25.9 percent. In Study 1, the decrease in lesion count from baseline to Week 12 was -17.4 for E-BPO cream, 5%, versus -9.5 for vehicle. In Study 2, the respective values were -20.3 and -13.3 (all P<0.001). The difference was also significant at Week 2. There were no treatment-related serious adverse events; 1.4 percent of subjects (1.8% E-BPO cream, 5%, 0.4% vehicle) discontinued due to adverse events. Assessed local tolerability was found to be similar among subjects in both E-BPO and vehicle. LIMITATIONS: E-BPO was not compared with unencapsulated BPO. CONCLUSION: E-BPO is an effective and well tolerated treatment for rosacea. Clinicaltrials.gov Identifiers: NCT03564119, NCT03448939. [ABSTRACT FROM AUTHOR]

Objective: We sought to evaluate the impact of the coronavirus-19 (COVID-19) pandemic on sun-seeking and sun-safe behaviors.Methods: We conducted an online, cross-sectional, population-based survey.Results: In total, 1,001 respondents participated in the survey and reported being exposed to 12 or more hours of sunlight (i.e., direct and indirect ultraviolet light, and blue light) each day. Participants self-reported a net increase in all types of light exposure since the onset of the COVID-19 pandemic, especially to blue light (+38%). Notably, while the effects of direct sunlight were well known among survey respondents, they were less aware of the potential damaging impact of indirect sunlight and blue light.Limitations: As the survey was only conducted among residents of the United States, results might not be generalizable to all geographical regions.Conclusion: Social outreach strategies are required to improve sun-safe behaviors. Future behavioral interventions should encourage the implementation of broad-spectrum sun protection. [ABSTRACT FROM AUTHOR]

Photodynamic therapy (PDT) can be an effective treatment for actinic keratosis (AK) as well as selected non-melanoma skin cancers (NMSCs), such as Bowen's disease and superficial basal cell carcinoma. PDT has also demonstrated effectiveness in the management of acne vulgaris. Results from controlled clinical trials have shown the safety and efficacy of PDT for these conditions with the use of different photosensitizers and a wide range of light sources. PDT has been employed effectively as monotherapy and in combination with other topicals and alternate light or laser energy therapies. This article provides expert practical guidance for the use of the newest 5-aminolevulinic acid (ALA) product (ALA 10% gel) plus red light as monotherapy for AKs, NMSC, and acne. Here, information from clinical guidelines and a summary of supporting evidence is provided for each cutaneous condition. The authors also provide detailed guidance for employing ALA 10% gel, a photosensitizer precursor, for each of these applications. [ABSTRACT FROM AUTHOR]

OBJECTIVE: This study was conducted to assess compatibility of tretinoin 0.05% acne lotion with foundation makeup. DESIGN: This was a single-center, evaluator-blinded, randomized, controlled clinical trial. Participants were randomized to apply tretinoin 0.05% lotion to either the right or left side of the face before applying full-face foundation makeup. SETTING: Participants were enrolled at a single center in the United States. PARTICIPANTS: Female individuals aged 18 to 50 years who used facial foundation makeup ≥5 days per week were included. MEASUREMENTS: Investigator-assessed grading for foundation coverage and participant evaluations of makeup appearance were conducted at post-makeup application (Post-Makeup) and Hour 6 (6H) timepoints. Antera 3D® images were taken for skin texture roughness analysis and tolerability evaluations were performed at baseline, post-tretinoin application, Post-Makeup, and 6H timepoints. RESULTS: A total of 30 participants were enrolled and 29 completed the study. There were no significant differences between tretinoin treated and untreated sides for any outcomes of investigator-assessed grading of foundation (percentage coverage, blotchiness, overall coverage, skin tone evenness, visual smoothness). There was a small but statistically significant worsening in percent coverage at 6H versus Post-Makeup on the untreated side, but not the treated side. As rated by participants, even/full coverage and skin smoothness were significantly better on the tretinoin-lotion treated versus the untreated side. Three-dimensional imaging showed there were no significant differences in skin roughness between the treated and untreated sides. Participants reported overall satisfaction with the tretinoin lotion-treated side. CONCLUSION: Tretinoin 0.05% lotion did not interfere with facial makeup application or wearability and was well tolerated. [ABSTRACT FROM AUTHOR]

OBJECTIVE: This study was conducted to assess compatibility of tretinoin 0.05% acne lotion with foundation makeup. DESIGN: This was a singlecenter, evaluator-blinded, randomized, controlled clinical trial. Participants were randomized to apply tretinoin 0.05% lotion to either the right or left side of the face before applying full-face foundation makeup. SETTING: Participants were enrolled at a single center in the United States. PARTICIPANTS: Female individuals aged 18 to 50 years who used facial foundation makeup =5 days per week were included. MEASUREMENTS: Investigator-assessed grading for foundation coverage and participant evaluations of makeup appearance were conducted at post-makeup application (Post-Makeup) and Hour 6 (6H) timepoints. Antera 3D® images were taken for skin texture roughness analysis and tolerability evaluations were performed at baseline, post-tretinoin application, Post-Makeup, and 6H timepoints. RESULTS: A total of 30 participants were enrolled and 29 completed the study. There were no significant differences between tretinoin treated and untreated sides for any outcomes of investigatorassessed grading of foundation (percentage coverage, blotchiness, overall coverage, skin tone evenness, visual smoothness). There was a small but statistically significant worsening in percent coverage at 6H versus Post-Makeup on the untreated side, but not the treated side. As rated by participants, even/full coverage and skin smoothness were significantly better on the tretinoin-lotion treated versus the untreated side. Three-dimensional imaging showed there were no significant differences in skin roughness between the treated and untreated sides. Participants reported overall satisfaction with the tretinoin lotion-treated side. CONCLUSION: Tretinoin 0.05% lotion did not interfere with facial makeup application or wearability and was well tolerated. [ABSTRACT FROM AUTHOR]

In-vitro and in-vivo studies have supported antimicrobial, anti-inflammatory, and other biologic properties of hypochlorous acid (HOCl), which has led to its use in the treatment of skin wounds, pruritus, diabetic ulcers, and some inflammatory skin disorders. Research has also shown that the physiochemical properties of HOCl after application to skin are highly dependent on both pH and formulation stability. In this review, the authors discuss a core HOCI formulation (Microcyn® Technology, Sonoma Pharmaceuticals, Petaluma, California) that is stable for up to two years, noncytotoxic, and pH-neutralized to augment therapeutic activity, skin tolerability, and stability. The authors summarize relevant study outcomes and potential modes of action related to this core HOCI formulation, as well as describe its ready-to-use vehicles that are approved and available for topical application. [ABSTRACT FROM AUTHOR]

Background: Topical corticosteroids (TCS) represent a mainstay of psoriasis treatment, though more potent formulations are not recommended for use for more than 2 to 4 weeks. Objective: We sought to investigate the safety and efficacy of once-daily halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion and halobetasol propionate 0.05% cream in patients with moderate-to-severe plaque psoriasis. Methods: This was a multicenter, randomized, double-blind, parallel-group, vehicle-controlled Phase II study (n=154). Patients were randomized (2:2:1) to HP 0.01%/TAZ 0.045% lotion, halobetasol propionate 0.05% cream, or vehicle, applied topically once daily for two weeks. Efficacy assessments included treatment success, impact on individual psoriasis signs (i.e., erythema, plaque elevation, and scaling) at target lesion, and body surface area (BSA). Safety and adverse events (AEs) were evaluated throughout. Results: HP/TAZ lotion was significantly more effective than vehicle and was comparable to halobetasol propionate 0.05% cream in reducing erythema, plaque elevation, and scaling. Of the HP/TAZ patients, 32.8 percent achieved treatment success versus 34.0 and 3.3 percent in the halobetasol and vehicle groups. At Week 2, treatment success was seen in 34.4 percent (erythema), 54.1 percent (plaque elevation), and 60.7 percent (scaling) of patients versus in 43.5, 50.8, and 50.8 percent receiving halobetasol. A 25.0- and 24.8-percent reduction in BSA occurred, respectively. The most frequently reported, treatment-related AE was application site pain. Conclusions: The efficacy of HP/TAZ lotion was comparable to a higher concentration of 0.05% halobetasol cream, showing rapid treatment success after two weeks with good safety. [ABSTRACT FROM AUTHOR]

Background: Cosmetic compatibility in the treatment of acne is an important issue significantly impacting quality of life, but often overlooked, as dermatologists commonly recommended avoidance of cosmetic foundations when treating adult female patients. Fixed combinations of clindamycin/benzoyl peroxide are widely used in the treatment of acne, but little is known about the impact of their concomitant use with facial foundation.Objective: To assess the compatibility of clindamycin phosphate 1. 2%/benzoyl peroxide 3. 75% gel with foundation makeup for up to six hours after application.Methods: Twenty-nine female subjects applied makeup to their face after randomly applying clindamycin phosphate 1. 2%/benzoyl peroxide 3. 75% gel to one side of the face. Investigator and subject self- assessment included facial skin attributes, facial tolerability, and cosmetic compatibility post-application and at Hour 6; as well as cutaneous tolerability.Results: No statistical difference was noted between the treated and untreated side of the face in terms of coverage, blotchiness, appearance, skin tone, or visual smoothness. Tolerability was excellent, with no erythema, edema, dryness, and peeling post-makeup application. For both the treated and untreated side, there was a slight lack of improvement in cosmetic appearance six hours post-makeup application.Conclusion: Clindamycin/benzoyl peroxide 3. 75% gel was shown to have excellent cosmetic compatibility with facial foundation. [ABSTRACT FROM AUTHOR]

OBJECTIVE: We sought to assess the long-term safety and tolerability of microencapsulated benzoyl peroxide cream, 5% (E-BPO cream, 5%), in 7 subjects with rosacea. Efficacy and tolerability have been previously demonstrated in two 12-week, randomized, double-blind, vehicle-controlled Phase Ill trials. METHODS: In this open-label extension study (NCT03564145; clinicaltrials.gov), all subjects from the initial placebo-controlled Phase Ill trials could receive E-BPO cream, 5%, for up to an additional 40 weeks, up to a total of 52 weeks of E-BPO cream, 5%, exposure. If a subject was assessed at study visits as "clear' or "almost clear' using the 5-point Investigator Global Assessment (IGA) scale (IGA O or 1), E-BPO cream, 5%, was not dispensed. If a subject was assessed as "mild to severe" (IGA 2+ ), E-BPO cream, 5%, was applied daily until they reached "clear' or "almost clear:' RESULTS: The safety and tolerability profile for E-BPO cream, 5%, was similar to that reported in the Phase Il l studies. Five subjects (0.9%) discontinued study drug due to treatment-related adverse events, and 17 subjects (3.2%) experienced an adverse event considered related to study drug. I GA success after 40 weeks of active treatment was 66.5 percent for subjects continuing from the Phase Il l vehicle group (n= 172) and 67.6 percent for subjects who continued Phase Ill E-BPO cream, 5% (n=363). The study ended early in accordance with the protocol. LIMITATIONS: Safety and tolerability of E-BPO were not compared with those of unencapsulated BPO. CONCLUSION: E-BPO cream, 5%, showed a favorable safety and tolerability profile during this 40-week, open-label extension study. [ABSTRACT FROM AUTHOR]

Objective: Tildrakizumab, an anti–interleukin-23 p19 monoclonal antibody, is approved for the treatment of adults with moderate-to-severe plaque psoriasis. Limited evidence is available regarding the effects of tildrakizumab on patient-reported symptoms and satisfaction. This report describes the secondary endpoints of patient-reported symptoms and treatment satisfaction over 64 weeks in patients with moderate-to-severe plaque psoriasis treated with tildrakizumab in a Phase IV, real-world study. Methods: In this uncontrolled, open-label study (NCT03718299), patients received tildrakizumab 100 mg at baseline, Week (W)4, and every 12 weeks thereafter to W52, with the final assessment at W64. Patient-reported secondary endpoints included numerical rating scale (NRS) scores for itch, pain, and scaling, and treatment satisfaction measured by 3 rating scales (Treatment Satisfaction Questionnaire for Medication [TSQM], Tildrakizumab Overall Satisfaction, and Patient Happiness with Psoriasis Control instrument) through W64. Results: Of the 55 patients enrolled, 45 were assessed at W64. Mean NRS scores for itch, pain, and scaling all decreased from baseline beginning as early as W4 with maintenance through W64 (P≤0.001). Treatment satisfaction was positive throughout treatment based on all 3 measures. Mean±SD TSQM domain scores increased from 59.5±17.0 at W4 to 79.5±20.1 at W64 for Effectiveness and from 72.7±18.6 to 81.9±20.5 for Global Satisfaction. Limitations: The study is small and lacks a comparator arm. Conclusion: Tildrakizumab treatment improved patient-reported symptoms in patients with moderate-to-severe plaque psoriasis in a real-world setting and was associated with high levels of treatment satisfaction over 64 weeks. [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]

Objective: Subantibiotic dose doxycycline (SDD40), formulated as a modified-release 40mg capsule administered once daily, is used to treat inflammatory lesions of rosacea. In order to investigate whether the patient's weight or lesion severity impacts clinical outcomes with using SDD40, the efficacy and safety of SDD40 in treating rosacea were evaluated in randomized controlled studies (RCTs).Methods: Phase II, III, and IV RCTs, and a subsequent meta-analysis were described. For all studies, the primary efficacy endpoint was the change in total inflammatory lesion count (papules, pustules, and nodules) from baseline to Week 16. For one of the studies, body weights were categorized by BMI (body mass index). Secondary efficacy endpoints included the change in Investigator's Global Assessment (IGA). Safety was assessed by monitoring adverse events (AEs).Results: The efficacy of SDD40 was consistent across the studies (two trials including n=72 and n=91 subjects) and meta-analysis (n=127 and n=142). SDD40 remained effective regardless of baseline disease severity and weight (with a weak correlation coefficient below 0.75); overweight or obese subjects with severe rosacea cleared at least as well if not better than those with a normal BMI and mild disease. The treatment was well tolerated with no to minimal gastrointestinal-related AEs.Limitations: Retrospective analyses have methodological limitations.Conclusion: Consistency between study results including the meta-analysis supports the effectiveness and safety of SDD40, irrespective of the weight of the patient or rosacea severity based on inflammatory lesion count at baseline. [ABSTRACT FROM AUTHOR]

BACKGROUND: Actinic keratoses (AKs) are precancerous, dysplastic, epidermal lesions caused by chronic sun exposure that may progress to squamous cell carcinoma. Aminolevulinic acid 20% solution with blue light photodynamic therapy (ALA-PDT) has previously been shown to be superior to vehicle plus PDT (VEHPDT) for treatment of AKs of the face, scalp, and upper extremities. OBJECTIVE: We report detailed patient satisfaction data for ALA-PDT. METHODS: Patient satisfaction for ALA-PDT versus VEH-PDT and patient-reported acceptability of ALA-PDT versus previous treatments for AKs were assessed in three randomized, vehicle-controlled studies (two Phase II and one Phase III) in adults. Patients in the Phase II studies were treated on the scalp and/or face, and those in the Phase III study were treated on the upper extremities. RESULTS: A total of 234, 166, and 269 patients were enrolled in the two Phase II studies and one Phase III study, respectively; overall, 79.8 percent of patients were male. Overall treatment satisfaction ranged from 79 to 88 percent for ALA-PDT, compared to 35 to 56 percent for VEH-PDT. Patients generally considered ALA-PDT to be equivalent to or more acceptable than prior treatments, including cryotherapy, 5-fluorouracil, imiquimod, previous PDT, and surgery. Similar proportions of patients receiving ALA-PDT or VEH-PDT on the upper extremities considered in-office time, side effects/adverse events (AEs), and duration of side effects/AEs to be acceptable. LIMITATIONS: The majority of patients were male, and no statistical comparisons were conducted. CONCLUSION: Patients were generally satisfied with ALA-PDT for the treatment of AKs of the face, scalp, and upper extremities and considered ALA-PDT to be equal to or more acceptable than previous treatments. [ABSTRACT FROM AUTHOR]

Background: Truncal acne is frequently underdiagnosed despite affecting around half of those with facial acne. The objective was to provide an overview of the literature on the incidence of truncal acne according to age, gender, and acne severity.Methods: A narrative review of data from recent large surveys and a literature search in PubMed on the incidence of truncal acne across subgroups of age, gender, and acne severity.Results: The prevalence of truncal acne alone was low, ranging from <1% to 14%, but approximately 30 to 60 percent of individuals with facial acne also had truncal acne depending on the population. In an online survey in the United States of 2,000 respondents aged between 14 -29 years with self-reported active facial and/or truncal acne, the incidence of truncal acne was lower in the 14-20 years subgroup than in the 21-29 years subgroup (49% vs 54%). The incidence of truncal acne was similar in both males and females, while 46 percent of respondents with self-declared clear and mild acne indicated having truncal involvement compared to 60 percent of those with moderate or severe acne.Limitations: Online surveys have inherent limitations, such as self-reporting and potential confounders.Conclusion: Data suggests that patients with both facial and truncal involvement have earlier onset of acne and more severe acne. Additional adverse psychological impact may arise from having the impression that the disease is spreading and becoming more severe. Raising awareness of truncal acne prevalence and demographics could improve its clinical management to reduce the negative psychological impact. [ABSTRACT FROM AUTHOR]

Rosacea is one of the most common inflammatory skin diseases in the United States, with a complex pathophysiology. One of the major components of the pathophysiology of rosacea is an abnormal immune detection and response to stimuli. Tetracyclines and their derivatives, including minocycline and doxycycline, have anti-inflammatory properties independent of their antibacterial activity that correlate with certain aspects of the pathophysiology, and these drugs are often used by dermatologists to treat rosacea. Biological actions of tetracyclines correlating with rosacea include anti-inflammatory and antioxidative activities, inhibitory effects on angiogenesis, and proteolysis. The objective of this review is to re-establish the current understanding of tetracyclines and their mechanism of action as they relate to the pathophysiology and treatment of rosacea for clinicians. This includes reviewing the inflammatory aspects of rosacea that correlate with the known nonantibiotic properties of tetracyclines and providing the most up-to-date clinical evidence supporting the use of tetracyclines to treat rosacea. Given the evolving and multifactorial nature of pathophysiology, this review offers clinicians a unified picture that includes research on the links between rosacea pathophysiology and clinical presentation, the nonantibiotic properties of tetracyclines that relate to pathophysiologic pathways in rosacea, and the potential for clinical application of tetracyclines in rosacea therapy. [ABSTRACT FROM AUTHOR]

Rosacea is one of the most common inflaammatory skin diseases in the United States, with a complex pathophysiology. One of the major components of the pathophysiology of rosacea is an abnormal immune detection and response to stimuli. Tetracyclines and their derivatives, including minocycline and doxycycline, have anti-inflaammatory properties independent of their antibacterial activity that correlate with certain aspects of the pathophysiology, and these drugs are often used by dermatologists to treat rosacea. Biological actions of tetracyclines correlating with rosacea include anti-inflaammatory and antioxidative activities, inhibitory effects on angiogenesis, and proteolysis. The objective of this review is to re-establish the current understanding of tetracyclines and their mechanism of action as they relate to the pathophysiology and treatment of rosacea for clinicians. This includes reviewing the inflaammatory aspects of rosacea that correlate with the known nonantibiotic properties of tetracyclines and providing the most up-to-date clinical evidence supporting the use of tetracyclines to treat rosacea. Given the evolving and multifactorial nature of pathophysiology, this review offers clinicians a uniffied picture that includes research on the links between rosacea pathophysiology and clinical presentation, the nonantibiotic properties of tetracyclines that relate to pathophysiologic pathways in rosacea, and the potential for clinical application of tetracyclines in rosacea therapy. [ABSTRACT FROM AUTHOR]

BACKGROUND: Efficacy and safety of FMX103 1.5% for papulopustular rosacea were previously demonstrated in two 12-week, Phase 3 studies. OBJECTIVE: We sought to evaluate the safety and efficacy of FMX103 1.5% foam for up to 52 weeks of treatment. METHODS: Following the completion of two 12-week, double-blind, vehicle-controlled, Phase 3 studies, subjects were invited to enter a 40-week open-label extension study in which all subjects applied FMX103 1.5% once daily. Efficacy endpoints were the reduction in inflammatory lesions and the rate of IGA treatment success from the double-blind baseline. Safety assessments included adverse events, vital signs, laboratory tests, and facial tolerability signs and symptoms. RESULTS: The favorable safety profile of FMX103 1.5% observed in the double-blind studies was maintained over extended treatment lasting up to one year. There were no serious treatment-related adverse events. Long-term treatment with FMX103 1.5% was associated with a greater than 82-percent reduction in inflammatory lesions from baseline and with over 79 percent of subjects achieving treatment success. At the end of the open-label treatment period, over 82 percent of subjects indicated they were overall "satisfied" or "very satisfied" with FMX103 1.5%. All facial local tolerability symptoms improved through Week 52. LIMITATIONS: Due to the nature of the open-label study, lacking a vehicle-treated control, no statistical comparisons can be made. CONCLUSION: FMX103 1.5% demonstrated a favorable safety and tolerability profile for up to 52 weeks. Long-term efficacy was demonstrated by progressive reductions in inflammatory lesions and increasing IGA treatment success, suggesting that FMX103 1.5% may be a suitable option for the treatment for papulopustular rosacea. [ABSTRACT FROM AUTHOR]

BACKGROUND: Efficacy and safety of FMX103 1.5% for papulopustular rosacea were previously demonstrated in two 12-week, Phase 3 studies. OBJECTIVE: We sought to evaluate the safety and efficacy of FMX103 1.5% foam for up to 52 weeks of treatment. METHODS: Following the completion of two 12-week, double-blind, vehicle-controlled, Phase 3 studies, subjects were invited to enter a 40-week open-label extension study in which all subjects applied FMX103 1.5% once daily. Efficacy endpoints were the reduction in inflammatory lesions and the rate of IGA treatment success from the double-blind baseline. Safety assessments included adverse events, vital signs, laboratory tests, and facial tolerability signs and symptoms. RESULTS: The favorable safety profile of FMX103 1.5% observed in the double-blind studies was maintained over extended treatment lasting up to one year. There were no serious treatment-related adverse events. Long-term treatment with FMX103 1.5% was associated with a greater than 82-percent reduction in inflammatory lesions from baseline and with over 79 percent of subjects achieving treatment success. At the end of the open-label treatment period, over 82 percent of subjects indicated they were overall "satisfied" or "very satisfied" with FMX103 1.5%. All facial local tolerability symptoms improved through Week 52. LIMITATIONS: Due to the nature of the open-label study, lacking a vehicletreated control, no statistical comparisons can be made. CONCLUSION: FMX103 1.5% demonstrated a favorable safety and tolerability profile for up to 52 weeks. Long-term efficacy was demonstrated by progressive reductions in inflammatory lesions and increasing IGA treatment success, suggesting that FMX103 1.5% may be a suitable option for the treatment for papulopustular rosacea. [ABSTRACT FROM AUTHOR]