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A Bioequivalence Study With Clinical Endpoints Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) in the Treatment of Mild to Severe Acne Vulgaris

NCT01501799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 885

Last updated 2011-12-29

No results posted yet for this study

Summary

EPIDUO™ (adapalene and benzoyl peroxide) Gel 0.1%/2.5%, marketed by GALDERMA LABORATORIES, L.P., 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 and benzoyl peroxide topical gel 0.1%/2.5%,and the current study is designed to evaluate the safety and efficacy of this formulation to determine if it is bioequivalent to EPIDUO™.

Conditions

  • Acne Vulgaris

Interventions

DRUG

adapalene 0.1% and benzoyl peroxide 2.5% topical gel

Dosage form: topical gel Dosage: A pea-sized amount was applied to each affected area of the face Frequency: once daily in the evening Duration: 12 weeks

DRUG

EPIDUO

EPIDUO (adapalene 0.1% and benzoyl peroxide 2.5%) Gel

DRUG

Placebo (Vehicle Gel)

Vehicle Gel

Sponsors & Collaborators

  • Actavis Mid-Atlantic LLC

    lead INDUSTRY

Principal Investigators

  • Nagashayana G., M.D. · Lotus Labs Pvt Ltd

  • Nermina Nakas, M.D., M.P.H. · Jubilant Clinsys, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States
  • Belize
  • India

Study Locations

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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 NCT01501799 on ClinicalTrials.gov