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Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne

NCT00713609 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 591

Last updated 2017-03-06

Study results available
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Summary

Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris.

You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Benzoyl peroxide gel

5% benzoyl peroxide in a gel applied topically once a day

DRUG

Clindamycin gel

1% clindamycin phosphate applied topically once a day

DRUG

Tazarotene cream

0.1 % tazarotene in a cream applied topically once a day

DRUG

Vehicle gel

Vehicle gel is an identical gel without the active ingredients

DRUG

Vehicle cream

Vehicle cream is an identical cream without the active ingredients

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Stiefel, a GSK Company

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT00713609 on ClinicalTrials.gov