Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd., Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to a Comparator Clindamycin / Benzoyl Peroxide Topical Gel, and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
1 other identifier
interventional
1,555
0 countries
N/A
Brief Summary
The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2009
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 4, 2010
CompletedFirst Posted
Study publicly available on registry
June 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
March 29, 2016
CompletedOctober 13, 2021
October 1, 2021
1 year
June 4, 2010
January 5, 2016
October 11, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Percent Change From Baseline in Inflammatory Lesions
10 weeks
Percent Change From Baseline in Non-inflammatory Lesions
10 weeks
Secondary Outcomes (1)
Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)
10 weeks
Study Arms (3)
Clindamycin 1%/Benzoyl Peroxide 5%
ACTIVE COMPARATORReference Product
ACTIVE COMPARATORVehicle
PLACEBO COMPARATORInterventions
Applied to the entire face twice daily for 10 weeks
Applied to the entire face twice daily for 10 weeks
Eligibility Criteria
You may qualify if:
- Healthy men or women, 12 to 65 years of age
- Willing to participate and sign provide written consent
- Moderate to severe acne
You may not qualify if:
- Pregnant or lactating women
- History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or lincomycin
- Use of systemic, topical or facial products which may interfere with the study
- Participation in any clinical study in the 30 days prior to study entry
- Prolonged exposure to sunlight or excessive exposure to UV lights
- Chronic use of NSAIDS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Padagis LLClead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jonathan Schwartz
- Organization
- Perrigo
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2010
First Posted
June 7, 2010
Study Start
October 1, 2009
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
October 13, 2021
Results First Posted
March 29, 2016
Record last verified: 2021-10