Adapalene/benzoyl peroxide 0.3%/2.5%: An effective acne therapy regardless of age or gender

Background: Age and gender have become increasingly important considerations in acne therapy. Adapalene plus benzoyl peroxide (A/BPO) is a first-line recommended acne therapy. In 2015, the FDA approved a higher concentration A/BPO for the treatment of acne vulgaris, A/BPO gel 0.3%/2.5%. We sought to investigate the influence of gender and age on the efficacy and safety of topical A/BPO 0.3%/2.5%. Methods: This was a post hoc subanalysis of a multicenter, randomized, double-blind, parallel group, 12-week, vehicle- and active-controlled study of A/BPO gel 0.3%/2.5% and vehicle gel treatment in men and women ≥12 years old with moderate to severe acne vulgaris (Investigator global assessment [IGA] of 3 or 4). Efficacy measurements included success rate, change in inflammatory/noninflammatory lesions from baseline to week 12, safety, and tolerability. The intent to treat (ITT) and safety populations were analyzed. Demographics and disposition were analyzed using descriptive statistics, categorical variables by frequency and percentage, and continuous variables by means and the standard error of the means. Results: The A/BPO gel 0.3%/2.5% treatment group included 217 subjects. By age: 111 were ≤ 17 years old, and 106 were ≥ 18 years old. By gender: 104 were men, and 113 were women. Regardless of age or gender, A/BPO 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle in success, inflammatory lesion reduction, and noninflammatory lesion reduction (P ≤ .05). Summary: A/BPO 0.3%/2.5% reduced lesion counts and was a safe and effective acne therapy regardless of age or gender. These results support the use of A/BPO 0.3%/2.5% as a first line acne therapy in all subjects 12 and older

Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris--A randomized phase II study.

BackgroundAn aerosol foam formulation of fixed combination calcipotriene 0.005% (as hydrate; Cal) plus betamethasone dipropionate 0.064% (BD) was developed to improve psoriasis treatment.ObjectivesTo compare the efficacy and safety of Cal/BD aerosol foam with Cal/BD ointment after 4 weeks.MethodsIn this Phase II, multicenter, investigator-blind, 4-week trial, adult patients with psoriasis vulgaris were randomized to Cal/BD aerosol foam, Cal/BD ointment, aerosol foam vehicle or ointment vehicle (3:3:1:1). The primary efficacy endpoint was the proportion of patients at week 4 who achieved treatment success (clear or almost clear with at least a two-step improvement) according to the physician's global assessment of disease severity.ResultsIn total, 376 patients were randomized. At week 4, significantly more patients using Cal/BD aerosol foam achieved treatment success (54.6% versus 43.0% [ointment]; p = 0.025); mean modified (excluding the head, which was not treated) psoriasis area and severity index score was significantly different between Cal/BD aerosol foam and Cal/BD ointment (mean difference -0.6; p = 0.005). Rapid, continuous itch relief occurred with both active treatments. One adverse drug reaction was reported with Cal/BD aerosol foam (application site itch).ConclusionsCal/BD aerosol foam demonstrates significantly greater efficacy and similar tolerability compared with Cal/BD ointment for psoriasis treatment

Long-term Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From an Extension of Two Phase III, Vehicle-controlled Trials

OBJECTIVE: We sought to assess the long-term safety and tolerability of microencapsulated benzoyl peroxide cream, 5% (E-BPO cream, 5%), in subjects with rosacea. Efficacy and tolerability have been previously demonstrated in two 12-week, randomized, double-blind, vehicle-controlled Phase III trials. METHODS: In this open-label extension study (NCT03564145; clinicaltrials.gov), all subjects from the initial placebo-controlled Phase III 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 0 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 III 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. IGA success after 40 weeks of active treatment was 66.5 percent for subjects continuing from the Phase III vehicle group (n=172) and 67.6 percent for subjects who continued Phase III 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

Long-term Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From an Extension of Two Phase III, Vehicle-controlled Trials

OBJECTIVE: We sought to assess the long-term safety and tolerability of microencapsulated benzoyl peroxide cream, 5% (E-BPO cream, 5%), in subjects with rosacea. Efficacy and tolerability have been previously demonstrated in two 12-week, randomized, double-blind, vehicle-controlled Phase III trials. METHODS: In this open-label extension study (NCT03564145; clinicaltrials.gov), all subjects from the initial placebo-controlled Phase III 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 0 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 III 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. IGA success after 40 weeks of active treatment was 66.5 percent for subjects continuing from the Phase III vehicle group (n=172) and 67.6 percent for subjects who continued Phase III 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