Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
NCT ID: NCT04321070
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
550 participants
INTERVENTIONAL
2019-09-09
2020-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Clindamycin Phosphate
Topical, once daily, for 84 days.
Clindamycin Phosphate
A thin film of investigation product will be applied to the affected areas of the face once daily
Clindamycin Phosphate RLD
Topical, once daily, for 84 days
Clindamycin Phosphate RLD
A thin film of investigation product will be applied to the affected areas of the face once daily
Vehicle of the test product
Topical, once daily, for 84 days
Placebos
A thin film of investigation product will be applied to the affected areas of the face once daily
Interventions
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Clindamycin Phosphate
A thin film of investigation product will be applied to the affected areas of the face once daily
Clindamycin Phosphate RLD
A thin film of investigation product will be applied to the affected areas of the face once daily
Placebos
A thin film of investigation product will be applied to the affected areas of the face once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent.
* Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).
Exclusion Criteria
* Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.
12 Years
40 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Natalie Yantovskiy
Role: STUDY_DIRECTOR
Taro Pharmaceuticals, Inc.
Locations
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Catawba Research LLC
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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CLPL 1907
Identifier Type: -
Identifier Source: org_study_id
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