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

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Tretinoin cream, 0.05%

RETIN-A® (tretinoin) cream, 0.05%

Vehicle of the test product

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Catawba Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tretinoin cream, 0.05%

RETIN-A® (tretinoin) cream, 0.05%

Vehicle of the test product

Arm Description

Apply once a day application, under at-home use conditions.

Outcomes

Primary Outcome Measures

Demonstration of Bioequivalence

Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts

Secondary Outcome Measures

Full Information

NCT ID

NCT03433378

First Posted

January 29, 2018

Last Updated

May 16, 2018

Sponsor

Taro Pharmaceuticals USA

1. Study Identification

Unique Protocol Identification Number

NCT03433378

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

August 4, 2017 (Actual)

Primary Completion Date

January 26, 2018 (Actual)

Study Completion Date

January 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taro Pharmaceuticals USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Bioequivalence

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

700 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tretinoin cream, 0.05%

Arm Type

Active Comparator

Arm Description

Apply once a day application, under at-home use conditions.

Arm Title

RETIN-A® (tretinoin) cream, 0.05%

Arm Type

Active Comparator

Arm Description

Apply once a day application, under at-home use conditions.

Arm Title

Vehicle of the test product

Arm Type

Placebo Comparator

Arm Description

Apply once a day application, under at-home use conditions.

Intervention Type

Drug

Intervention Name(s)

Tretinoin cream, 0.05%

Other Intervention Name(s)

Tretinoin

Intervention Description

Tretinoin cream, 0.05%

Intervention Type

Drug

Intervention Name(s)

RETIN-A® (tretinoin) cream, 0.05%

Other Intervention Name(s)

Tretinoin

Intervention Description

RETIN-A® (tretinoin) cream, 0.05%

Intervention Type

Drug

Intervention Name(s)

Vehicle of the test product

Other Intervention Name(s)

placebo

Intervention Description

Vehicle of the test product

Primary Outcome Measure Information:

Title

Demonstration of Bioequivalence

Description

Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Natalie Yantovskiy

Organizational Affiliation

Taro Pharmaceuticals Inc

Official's Role

Study Director

Facility Information:

Facility Name

Catawba Research, LLC

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28217

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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