NCT01095640

A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study Comparing 0.3% Adapalene Topical Gel (Actavis Mid Atlantic LLC) to Differin® (0.3 % Adapalene Topical Gel) (Galderma Laboratories, L.P.) and Both Active Treatments to a Vehicle Control (Actavis Mid Atlantic LLC) in the Treatment of Mild to Moderate Acne Vulgaris

Completed NA Last updated 29 March 2010

What this trial tests

NA trial testing adapalene 0.3% topical gel in Acne Vulgaris in 1,159 participants. Completed in 1 December 2009.

Timeline

1 March 2009

Primary endpoint
1 December 2009

1 December 2009

Quick facts

Lead sponsor	Actavis Mid-Atlantic LLC
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,159
Start date	1 March 2009
Primary completion	1 December 2009
Estimated completion	1 December 2009
Sites	1 location across India

Drugs / interventions tested

• adapalene 0.3% topical gel — full drug profile →

Conditions studied

• Acne Vulgaris — all drugs for Acne Vulgaris →

Sponsor

Actavis Mid-Atlantic LLC — full company profile →

Who can join

12 and older, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Therapeutic Equivalence
  Time frame: 12 weeks
  The primary equivalence comparison is that between the test and reference products for the mean percent change from baseline in the inflammatory lesion counts, the non-inflammatory lesion counts and the proportion of "success" patients at Visit 5, as measured using the Investigator's Global Evaluation (IGE).
• Superiority
  Time frame: 12 Weeks
  The primary superiority evaluations are the comparisons between each active treatment and the vehicle control relative to the mean percent change in the inflammatory lesion counts, the non-inflammatory lesion counts and the proportion of "success" patients at Visit 5, as measured using the IGE.
• Safety
  Time frame: 12 Weeks
  All treatment-emergent adverse events reported during the study will be summarized in order to assess safety.

Sponsor's own description

Marketed by Galderma Laboratories, L.P., Differin® (adapalene 0.3% topical gel) is a safe and effective topical therapy used for the treatment of acne vulgaris. Actavis Mid-Atlantic LLC has developed a generic formulation of adapalene 0.3% topical gel and the current study is designed to evaluate the safety and efficacy of this formulation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.