Conditions: Acne Vulgaris
Keywords: acne irritation objective sensory methods
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 247
Healthy volunteers: no

Brief summary:
A study to determine if using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.

Detailed description:
Approximately 240 subjects will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, all subjects will receive RETIN-A MICRO PUMP 0.04% and a 5% Benzoyl Peroxide wash (OTC) for the entire 12-week treatment period. Subjects will be randomized to either both morning treatments (test) or to the morning/evening treatment (active control). Subjects will be assessed at baseline, at week 3, week 6 and again at the end of therapy, week 12 for number and type of individual lesions and safety. At selected sites, photographs will be taken at the same time points. At Week 12 subjects will be assessed for Investigator's Global Assessment of Acne Severity. The investigator will conduct all of the lesion counts, global assessments and safety assessments.

Arms:
arm 1: 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day arm 2: 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening

Interventions: intervention 1: benzoyl peroxide wash intervention 2: Tretinoin gel
Intervention descriptions: intervention 1: 5% benzoyl peroxide wash intervention 2: 0.04% tretinoin gel

Protocol document: