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Clinical End Point Study of Generic Adapalene and Benzoyl Peroxide Gel Versus Epiduo® Forte Gel in Treatment of Acne Vulgaris

NCT02651220 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1001

Last updated 2020-06-23

Study results available
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Summary

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of adapalene and benzoyl peroxide gel, 0.3%/2.5% (Actavis Laboratories UT, Inc.) to Epiduo® Forte (adapalene and benzoyl peroxide) gel 0.3%/2.5% (Galderma) in the treatment of Acne Vulgaris

Conditions

Interventions

DRUG

Epiduo® Forte Gel

Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w

DRUG

Adapalene and Benzoyl Peroxide Gel

Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w

DRUG

placebo gel

vehicle used as placebo

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-04-30
Completion
2016-10-31

Countries

  • United States
  • Belize

Study Locations

More Related Trials

Entities

Diseases

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 NCT02651220 on ClinicalTrials.gov