NCT00907257

A Study of Different Use Regimens Using Two Acne Treatments

A Clinical Assessment of the Use of RETIN-A MICRO (Tretinoin Gel) Microsphere, 0.04% in a Pump Dispenser and a 5% Benzoyl Peroxide Wash Used in the Morning Compared to the Use of RETIN-A MICRO 0.04% Pump Nightly and a 5% Benzoyl Peroxide Wash in the Morning For the Treatment of Facial Acne Vulgaris

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	benzoyl peroxide wash	5% benzoyl peroxide wash
DRUG	Tretinoin gel	0.04% tretinoin gel

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2009-05-22
• Last updated: 2012-02-15
• Results posted: 2011-01-21

Locations

12 sites across 1 country: United States