To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.05% to RETIN-A® (TRETINOIN) CREAM, 0.05% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
1 other identifier
interventional
700
1 country
1
Brief Summary
Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2017
Shorter than P25 for early_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
August 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2018
CompletedFirst Submitted
Initial submission to the registry
January 29, 2018
CompletedFirst Posted
Study publicly available on registry
February 14, 2018
CompletedMay 18, 2018
May 1, 2018
6 months
January 29, 2018
May 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Demonstration of Bioequivalence
Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts
12 weeks
Study Arms (3)
Tretinoin cream, 0.05%
ACTIVE COMPARATORApply once a day application, under at-home use conditions.
RETIN-A® (tretinoin) cream, 0.05%
ACTIVE COMPARATORApply once a day application, under at-home use conditions.
Vehicle of the test product
PLACEBO COMPARATORApply once a day application, under at-home use conditions.
Interventions
RETIN-A® (tretinoin) cream, 0.05%
Vehicle of the test product
Eligibility Criteria
You may qualify if:
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below).
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 tretinoin, retinoids, or any of the study medication ingredients.
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)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Natalie Yantovskiy
Taro Pharmaceuticals Inc
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2018
First Posted
February 14, 2018
Study Start
August 4, 2017
Primary Completion
January 26, 2018
Study Completion
January 26, 2018
Last Updated
May 18, 2018
Record last verified: 2018-05