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NCT01044264 Clinical Trial

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

Acne Vulgaris Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01044264
Other study ID # DAC-501-601-727998
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2007
Est. completion date September 2008

Study information
Verified date July 2023
Source Padagis LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Other known NCT identifiers
  • NCT00807638

Recruitment information / eligibility
Status Completed
Enrollment 602
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 40 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Topical Gel
• Placebo
Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Padagis LLC

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction of Inflammatory Lesions 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
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