Back to resultsBio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Clindamycin Phosphate
Clindamycin Phosphate RLD
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris.
- 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:
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
- 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.
Sites / Locations
- Catawba Research LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Clindamycin Phosphate
Clindamycin Phosphate RLD
Vehicle of the test product
Arm Description
Topical, once daily, for 84 days.
Topical, once daily, for 84 days
Topical, once daily, for 84 days
Outcomes
Primary Outcome Measures
Demonstration of Bioequivalence
Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts
Secondary Outcome Measures
Full Information
NCT ID
NCT04321070
First Posted
March 23, 2020
Last Updated
March 23, 2020
Sponsor
Taro Pharmaceuticals USA
1. Study Identification
Unique Protocol Identification Number
NCT04321070
Brief Title
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
Official Title
A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
December 14, 2019 (Actual)
Study Completion Date
March 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
Detailed Description
Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
550 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clindamycin Phosphate
Arm Type
Experimental
Arm Description
Topical, once daily, for 84 days.
Arm Title
Clindamycin Phosphate RLD
Arm Type
Active Comparator
Arm Description
Topical, once daily, for 84 days
Arm Title
Vehicle of the test product
Arm Type
Placebo Comparator
Arm Description
Topical, once daily, for 84 days
Intervention Type
Drug
Intervention Name(s)
Clindamycin Phosphate
Other Intervention Name(s)
Lotion
Intervention Description
A thin film of investigation product will be applied to the affected areas of the face once daily
Intervention Type
Drug
Intervention Name(s)
Clindamycin Phosphate RLD
Other Intervention Name(s)
Lotion
Intervention Description
A thin film of investigation product will be applied to the affected areas of the face once daily
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Vehicle
Intervention Description
A thin film of investigation product will be applied to the affected areas of the face once daily
Primary Outcome Measure Information:
Title
Demonstration of Bioequivalence
Description
Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris.
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:
Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
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.
Facility Information:
Facility Name
Catawba Research LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28217
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
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