Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris

Allergan

Status and phase: Terminated; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: Adapalene; Drug: Tazarotene Cream 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00829049

MA-TAZ0702

Details and patient eligibility

About

Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris

Enrollment: 165 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Facial acne vulgaris characterized by the following: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater).
• Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study.

Exclusion criteria

• Non-compliance with washout period
• Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris
• Allergy or sensitivity to any component of the test medications
• Cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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165 participants in 2 patient groups

Tazarotene Cream 0.1%

Active Comparator group

Description:

1 pea-size amount, QD x 16 weeks

Treatment:

Drug: Tazarotene Cream 0.1%

Adapalene Gel 0.3%

Active Comparator group

Description:

1 pea-size amount, QD x 16 weeks

Treatment:

Drug: Adapalene