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Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris

NCT02616614 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 862

Last updated 2020-05-27

Study results available
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Summary

Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75% gel. This study is designed to evaluate the safety and efficacy of this formulation in subjects with Acne Vulgaris

Conditions

  • Acne Vulgaris

Interventions

DRUG

Onexton

Topical gel for treating acne

DRUG

Clindamycin/benzoyl peroxide gel

Generic Clindamycin/benzoyl peroxide gel for treating acne

DRUG

Placebo

Vehicle gel used as a placebo

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Henry lau, PhD · Actavis Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-10-31
Completion
2015-11-30

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT02616614 on ClinicalTrials.gov