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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02465632 |
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Date of registration:
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04/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) to the Marketed Product BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% (Valeant Pharmaceuticals, US) in the Treatment of Acne Vulgaris. |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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1100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02465632 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Belize
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United States
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Contacts
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Name:
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Mahesh V Deshpande |
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Address:
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Telephone:
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Email:
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Affiliation:
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Glenmark Pharmaceuticals Ltd |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male or non-pregnant, non-lactating female, =12 and =40 years of age with a clinical
diagnosis of acne vulgaris.
2. Have facial acne with: =20 facial inflammatory lesions (papules and pustules) and =25
non-inflammatory lesions (open and closed comedones), and =2 nodulocystic lesions
(nodules and cysts) and have an IGA score of 2, 3 or 4.
Exclusion Criteria:
1. Subject has more than 2 facial nodular lesions; any nodules present will be documented
but not included in the inflammatory lesion count for analysis.
2. Subject has active cystic acne.
3. Subject has acne conglobata.
4. Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that
would interfere with the diagnosis or assessment of acne.
Age minimum:
12 Years
Age maximum:
40 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acne Vulgaris
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Intervention(s)
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Drug: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
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Drug: Placebo
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Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
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Primary Outcome(s)
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Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)
[Time Frame: Baseline and 10 Weeks]
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Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)
[Time Frame: Baseline and 10 Weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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