Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris

Allergan

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: Dapsone; Drug: Tazarotene

Study type: Interventional

Funder types: Industry

Identifiers

NCT00834210

MA-ACZ0802

Details and patient eligibility

About

A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tazarotene cream 0.1% compared with tazarotene cream 0.1% monotherapy in treating moderate to severe facial acne vulgaris

Enrollment: 171 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, 3 or more nodules and/or cysts (diameter of 1cm or greater). 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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171 participants in 2 patient groups

1

Active Comparator group

Description:

Dapsone Gel 5% and Tazarotene Cream 0.1%

Treatment:

Drug: Dapsone

2

Active Comparator group

Description:

Tazarotene Cream 0.1%

Treatment:

Drug: Tazarotene