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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

753 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Adapalene Gel 0.3%

Adapalene Gel 0.3% (Taro Pharmaceuticals Inc.)

Group Type EXPERIMENTAL

Adapalene Gel 0.3%

Intervention Type DRUG

Adapalene Gel 0.3% applied to the entire face once daily for 84 consecutive days

Differin®

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

Group Type ACTIVE_COMPARATOR

Differin®

Intervention Type DRUG

Differin® applied to the entire face once daily for 84 consecutive days

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (vehicle of the test product) applied to the entire face once daily for 84 consecutive days

Interventions

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Adapalene Gel 0.3%

Adapalene Gel 0.3% applied to the entire face once daily for 84 consecutive days

Intervention Type DRUG

Differin®

Differin® applied to the entire face once daily for 84 consecutive days

Intervention Type DRUG

Placebo

Placebo (vehicle of the test product) applied to the entire face once daily for 84 consecutive days

Intervention Type DRUG

Other Intervention Names

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Adapalene Adapalene Vehicle

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No