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NCT03433378 Clinical Trial

To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03433378
Other study ID # TRTC 1623
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date August 4, 2017
Est. completion date January 26, 2018

Study information
Verified date May 2018
Source Taro Pharmaceuticals USA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.

Description:

A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.05% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.05% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris

Recruitment information / eligibility
Status Completed
Enrollment 700
Est. completion date January 26, 2018
Est. primary completion date January 26, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 40 Years
Eligibility Inclusion Criteria:

- 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).

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 tretinoin, retinoids, or any of the study medication ingredients.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tretinoin cream, 0.05%
Tretinoin cream, 0.05%
• RETIN-A® (tretinoin) cream, 0.05%
RETIN-A® (tretinoin) cream, 0.05%
• Vehicle of the test product
Vehicle of the test product

Locations
Country Name City State
United States Catawba Research, LLC Charlotte North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Demonstration of Bioequivalence Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts 12 weeks
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