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

Allergan

Status and phase

Completed

Phase 4

Conditions

Acne Vulgaris

Treatments

Drug: Tretinoin

Drug: Dapsone; Tretinoin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00835198

MA-ACZ0801

Details and patient eligibility

About

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

Enrollment

163 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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