Overview

A Study of Different Use Regimens Using Two Acne Treatments

Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bausch Health Americas, Inc.
Valeant Pharmaceuticals International, Inc.
Treatments:
Benzoyl Peroxide
Tretinoin
Criteria
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.