Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations

July 7, 2023 updated by: Padagis LLC

A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled Study Comparing Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations in the Treatment of Moderate to Severe Acne Vulgaris

A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel formulations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

602

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy men or women, 12 years of age and older
  • willing to participate and sign a copy of the informed consent form
  • moderate to severe facial acne

Exclusion Criteria:

  • history of allergy or hypersensitivity to clindamycin or benzoyl peroxide
  • pregnant or lactating women
  • evidence of a clinically significant disorder
  • receipt of any drugs as part of a research study within 30 days prior to study dosing
  • use of systemic, topical or facial products which may interfere with study
  • significant facial hair, tattoos, excessive facial scarring, active facial sunburn, or peeling due to sunburn

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Active Comparator: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Test product
Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Topical Gel
Other Names:
  • DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Active Comparator: DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Reference product
Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Topical Gel
Other Names:
  • DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Inflammatory Lesions
Time Frame: Baseline and week 11
The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).
Baseline and week 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Padagis LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimated)

January 7, 2010

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAC-501-601-727998

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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