Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations
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
1 other identifier
interventional
602
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2007
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 4, 2010
CompletedFirst Posted
Study publicly available on registry
January 7, 2010
CompletedResults Posted
Study results publicly available
December 17, 2012
CompletedJuly 12, 2023
July 1, 2023
9 months
January 4, 2010
September 14, 2012
July 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
1% Clindamycin/5% Benzoyl Peroxide Topical Gel
ACTIVE COMPARATORTest product
DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
ACTIVE COMPARATORReference product
Placebo
PLACEBO COMPARATORInterventions
Topical Gel
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Padagis LLClead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Manager
- Organization
- Perrigo Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2010
First Posted
January 7, 2010
Study Start
December 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
July 12, 2023
Results First Posted
December 17, 2012
Record last verified: 2023-07