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

Condition(s) targeted: Acne Vulgaris

Intervention: Dapsone; Tretinoin (Drug); Tretinoin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12

Secondary outcome:

Change From Baseline in Investigator Global Assessment at Week 12

Change From Baseline in Overall Disease Severity at Week 12

Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Exclusion Criteria:

- 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

Strongsville, Ohio, United States

Starting date: December 2008
Last updated: September 22, 2011