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A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris

NCT02578043 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 844

Last updated 2018-05-18

No results posted yet for this study

Summary

The objectives of this study are to evaluate the therapeutic equivalence and safety.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%

Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% (Taro Pharmaceuticals Inc.)

DRUG

Onexton™ Gel

Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) (Valeant Pharmaceuticals LLC)

DRUG

Placebo

Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Catawba Research · http://catawbaresearch.com/contact/

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-08-31
Completion
2015-09-30

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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 NCT02578043 on ClinicalTrials.gov