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Study Comparing Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% to Epiduo® and Both to a Placebo Control in the Treatment of Acne Vulgaris

NCT01742637 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2008

Last updated 2017-05-04

No results posted yet for this study

Summary

The objective of this study is to evaluate the therapeutic equivalence and safety of Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel (Taro Pharmaceuticals Inc.) and Epiduo® (Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel) (Galderma Laboratories, L.P.) in the treatment of acne vulgaris, and to demonstrate the superiority of the efficacy of the test and reference products over the vehicle (placebo) control in the treatment of acne vulgaris.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%

Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Taro Pharmaceuticals Inc.)applied topically once daily for 84 consecutive days.

DRUG

Epiduo® Gel

Epiduo® (Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%) (Galderma Laboratories, L.P.)applied topically once daily for 84 consecutive days.

DRUG

Placebo

Placebo (vehicle of test product) (Taro Pharmaceuticals Inc.)applied topically once daily for 84 consecutive days.

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Catawba Research · http://catawbaresearch.com/contact/

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-02-28
Completion
2014-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01742637 on ClinicalTrials.gov