A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne

Allergan

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: Dapsone plus Adapalene; Drug: Clindamycin/benzoyl peroxide plus Adapalene

Study type: Interventional

Funder types: Industry

Identifiers

NCT01231334

MA-ACZ1001

Details and patient eligibility

About

A study comparing the topical application of Aczone® plus Differin® versus Duac® plus Differin® in patients with severe facial acne (facial acne vulgaris).

Enrollment: 286 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe facial acne (acne vulgaris)

Exclusion criteria

• History of significant anemia or hemolysis
• History of enteritis (eg, regional enteritis, ulcerative colitis, pseudomembranous colitis, antibiotic-associated colitis)
• History of lupus, rosacea, or seborrheic dermatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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286 participants in 2 patient groups

Aczone® Gel 5% plus Differin® 0.3% Gel

Active Comparator group

Description:

Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks.

Treatment:

Drug: Dapsone plus Adapalene

Duac® Topical Gel plus Differin® 0.3% Gel

Active Comparator group

Description:

Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.

Treatment:

Drug: Clindamycin/benzoyl peroxide plus Adapalene