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Evaluate Therapeutic Equivalence and Safety of Two Clindamycin Phosphate and Benzoyl Peroxide Gels in Acne Vulgaris

NCT01788384 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 708

Last updated 2013-02-11

No results posted yet for this study

Summary

Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% gel marketed by Valeant Pharmaceuticals, North America, is a safe and effective topical therapy used for the treatment of acne vulgaris.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Clindamycin Phosphate / Benzoyl Peroxide Gel

Dosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes.

DRUG

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%

Dosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes.

DRUG

Placebo (Vehicle Gel)

Dosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes.

Sponsors & Collaborators

  • Watson Laboratories, Inc.

    lead INDUSTRY

Principal Investigators

  • John L Capicchioni · Akesis, LLC

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
2012-07-31
Primary Completion
2012-12-31
Completion
2012-12-31

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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 NCT01788384 on ClinicalTrials.gov