To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris

May 16, 2018 updated by: Taro Pharmaceuticals USA

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

455

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28217
        • Catawba Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 36 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tretinoin cream 0.1%
Once daily at home, to apply the entire affected areas of the face.
Drug: Tretinoin cream 0.1%
Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
Other Names:
  • Tretinoin
Active Comparator: RETIN-A® Cream
Once daily at home, to apply the entire affected areas of the face.
Drug: RETIN-A® Cream
RETIN-A® (Tretinoin) Cream (Valeant)
Other Names:
  • Tretinoin
Placebo Comparator: Vehicle of the test product
Once daily at home, to apply the entire affected areas of the face.
Drug: Vehicle of the test product
Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstration of Bioequivalence
Time Frame: 12 weeks
Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taro Pharmaceuticals USA

Investigators

  • Study Director: Zaidoon A Al-Zubaidy, Catawba Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2017

Primary Completion (Actual)

January 26, 2018

Study Completion (Actual)

January 26, 2018

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

February 7, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

May 18, 2018

Last Update Submitted That Met QC Criteria

May 16, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRTC 1622

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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