Status:
COMPLETED
A Study of Different Use Regimens Using Two Acne Treatments
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT00907257
Start Date
February 1 2009
End Date
September 1 2009
Last Update
February 15 2012
Active Locations (12)
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1
Skin Care Research, Inc.
Boca Raton, Florida, United States, 33486
2
International Dermatology Research, Inc.
Miami, Florida, United States, 33144
3
Gwinnett Clinical Research
Snellville, Georgia, United States, 30078
4
Derm Research, PLLC
Louisville, Kentucky, United States, 40217