A Study of Different Use Regimens Using Two Acne Treatments

Bausch Health

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: benzoyl peroxide wash; Drug: Tretinoin gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00907257

CA-P-6270

Details and patient eligibility

About

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.

Full 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.

Enrollment: 247 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and non-pregnant or non-nursing females, 12 years or older, with facial acne vulgaris;
• Minimum of 20 but no more than 50 inflammatory lesions (papules and pustules);
• Minimum of 30 but no more than 100 facial non-inflammatory lesions (open and closed comedones);
• Must have at least a rating of grade 3 on the Investigator Global severity scale at baseline

Exclusion criteria

• Known sensitivity to any of the ingredients in the study medication;
• Any nodulocystic acne lesions;
• Use of acne devices or systemic therapy with antibiotics within two months prior to start and throughout the duration of the study;
• Use of systemic therapy with retinoids within four months prior to study start and throughout the duration of the study;
• Topical use of retinoids within two weeks prior to study start and throughout the duration of the study;
• Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study;
• If subject is taking birth control pills, she must be stabilized for at least three months prior to study start;
• History of evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication;
• Any significant medical conditions that could confound the interpretation of the study;
• Excessive facial hair that may interfere with evaluations;
• No use of tanning booths, sun lamps, etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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247 participants in 2 patient groups

Same time of day

Experimental group

Description:

5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day

Treatment:

Drug: Tretinoin gel

Drug: benzoyl peroxide wash

Different times of day

Active Comparator group

Description:

5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening

Treatment:

Drug: Tretinoin gel

Drug: benzoyl peroxide wash