A Study of Different Use Regimens Using Two Acne Treatments

Completed · Phase 4

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT00907257

Run by

Bausch Health Americas, Inc.

People needed

247

Starts

2009-02-01

Expected to finish

2009-09-01

Last updated by the study team

2012-02-15

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Skin Care Research, Inc. — Boca Raton, Florida, United States
• International Dermatology Research, Inc. — Miami, Florida, United States
• Gwinnett Clinical Research — Snellville, Georgia, United States
• Derm Research, PLLC — Louisville, Kentucky, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• DermResearch Center of New York — Stony Brook, New York, United States
• Dermatology Research Associates — Cincinnatti, Ohio, United States
• Yardley Dermatology Associates — Yardley, Pennsylvania, United States
• DermResearch, Inc. — Austin, Texas, United States
• Education & Research Foundation, Inc. — Lynchburg, Virginia, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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