Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations
This study has been completed.
Sponsor:
Perrigo Company
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT01044264
First received: January 4, 2010
Last updated: January 17, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acne Vulgaris |
Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Acne
Drug Information available for:
Benzoyl peroxide
Clindamycin
Clindamycin hydrochloride
Clindamycin phosphate
Clindamycin palmitate hydrochloride
Clindamycin palmitate
U.S. FDA Resources
Further study details as provided by Perrigo Company:
Primary Outcome Measures:
- Reduction of Inflammatory Lesions [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).
| Enrollment: | 602 |
| Study Start Date: | December 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Test product
|
Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Topical Gel
Other Name: 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 Name: DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
No Contacts or Locations Provided
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Perrigo Company |
| ClinicalTrials.gov Identifier: | NCT01044264 History of Changes |
| Obsolete Identifiers: | NCT00807638 |
| Other Study ID Numbers: | DAC-501-601-727998 |
| Study First Received: | January 4, 2010 |
| Results First Received: | September 14, 2012 |
| Last Updated: | January 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Perrigo Company:
|
Acne Vulgaris bioequivalency clindamycin benzoyl peroxide |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Facial Dermatoses Sebaceous Gland Diseases Skin Diseases Benzoyl Peroxide Clindamycin Clindamycin palmitate Clindamycin phosphate |
Anti-Bacterial Agents Anti-Infective Agents Dermatologic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Synthesis Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015