Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
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
1 other identifier
interventional
550
1 country
1
Brief Summary
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2020
CompletedFirst Submitted
Initial submission to the registry
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 25, 2020
CompletedApril 10, 2025
April 1, 2025
3 months
March 23, 2020
April 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Demonstration of Bioequivalence
Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts
Week 12
Study Arms (3)
Clindamycin Phosphate
EXPERIMENTALTopical, once daily, for 84 days.
Clindamycin Phosphate RLD
ACTIVE COMPARATORTopical, once daily, for 84 days
Vehicle of the test product
PLACEBO COMPARATORTopical, once daily, for 84 days
Interventions
A thin film of investigation product will be applied to the affected areas of the face once daily
A thin film of investigation product will be applied to the affected areas of the face once daily
A thin film of investigation product will be applied to the affected areas of the face once daily
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catawba Research LLC
Charlotte, North Carolina, 28217, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Natalie Yantovskiy
Taro Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2020
First Posted
March 25, 2020
Study Start
September 9, 2019
Primary Completion
December 14, 2019
Study Completion
March 6, 2020
Last Updated
April 10, 2025
Record last verified: 2025-04