Study Comparing Adapalene Gel 0.3% to Differin® and Both to a Placebo Control in Treatment of Acne Vulgaris

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: Adapalene Gel 0.3%; Drug: Differin®; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02411942

ADPG 1410

Details and patient eligibility

About

The objectives of this study are to evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%).

Full description

The objectives of this study are to evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo.

Enrollment: 753 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
• Subjects aged 18 years and older must have provided written consent. Subjects aged 12 to 17 years must have provided written assent accompanied by written consent from their legally acceptable representative. All subjects or their legally acceptable representatives must sign Health Insurance Portability and Accountability Act authorization.
• Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
• Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion criteria

• Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
• Have a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients.
• Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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753 participants in 3 patient groups, including a placebo group

Adapalene Gel 0.3%

Experimental group

Description:

Adapalene Gel 0.3% (Taro Pharmaceuticals Inc.)

Treatment:

Drug: Adapalene Gel 0.3%

Differin®

Active Comparator group

Description:

Differin® (adapalene gel 0.3%) (Galderma Laboratories, LP, US)

Treatment:

Drug: Differin®

Placebo

Placebo Comparator group

Description:

Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)

Treatment:

Drug: Placebo