Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels
This study has been completed.
Sponsor:
Perrigo Company
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT01138514
First received: June 4, 2010
Last updated: June 19, 2012
Last verified: June 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo) Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Acne
Drug Information available for:
Benzoyl peroxide
Clindamycin hydrochloride
Clindamycin phosphate
Clindamycin palmitate hydrochloride
Clindamycin palmitate
U.S. FDA Resources
Further study details as provided by Perrigo Company:
Primary Outcome Measures:
- Mean percent change from baseline in both inflammatory and non-inflammatory lesions [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 1555 |
| Study Start Date: | October 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Clindamycin 1%/Benzoyl Peroxide 5% |
Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)
Applied to the entire face twice daily for 10 weeks
|
| Active Comparator: Reference Product |
Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)
Applied to the entire face twice daily for 10 weeks
|
| Placebo Comparator: Vehicle |
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 12 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Healthy men or women, 12 to 65 years of age
- Willing to participate and sign provide written consent
- Moderate to severe acne
Exclusion Criteria:
- 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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Perrigo Company |
| ClinicalTrials.gov Identifier: | NCT01138514 History of Changes |
| Other Study ID Numbers: | PRG-716 |
| Study First Received: | June 4, 2010 |
| Last Updated: | June 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Benzoyl Peroxide Clindamycin Clindamycin-2-phosphate |
Dermatologic Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 16, 2013