Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris

Completed · Phase 4

Conditions studied: Acne Vulgaris

In brief

A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris

Key facts

Study ID

NCT00835198

Run by

Allergan

People needed

163

Starts

2008-12-01

Expected to finish

2009-08-01

Last updated by the study team

2011-10-31

Who can join

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

You may qualify if…

• Facial acne vulgaris characterized by the following:
• 30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions;
• Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm)
• Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study

You may not qualify if…

• Non-compliance with washout period;
• History of clinically significant anemia or hemolysis;
• Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris;
• Allergy or sensitivity to any component of the test medications

Where it is running

• Study site — Strongsville, Ohio, United States

Full record on ClinicalTrials.gov

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