To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% 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, 0.1% to RETIN-A® (TRETINOIN) CREAM, 0.1% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427554
• Other study ID #: TRTC 1622
• Status: Completed
• Phase: Early Phase 1
• Start date: August 21, 2017
• Est. completion date: January 26, 2018

Study information

• Verified date: May 2018
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.

Description:

A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.1% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.1% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• 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).

• Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.

Exclusion Criteria:

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Tretinoin cream 0.1%
Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
• RETIN-A® Cream
RETIN-A® (Tretinoin) Cream (Valeant)
• Vehicle of the test product
Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)

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