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Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Adapalene Gel, 0.1%

Tazarotene Cream, 0.1%

Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face
Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose

Exclusion Criteria:

Subjects with more than 3 nodulo-cystic lesions

Sites / Locations

Therapeutics Clinical Research
Henry Ford Medical Center-Dept. of Dermatology
Minnesota Clinical Study Center
State University of New York Downstate Medical Center-Dept. of Dermatology
Dermatology Research Associates
Phoebe Rich, MD & Associates
Milton S. Hershey Medical Center Center-Div. of Dermatology
DermResearch, Inc.
J & S Studies, Inc.
Stephens & Associates
Dermatology Research Center
Virginia Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm Description

Differin® Gel, 0.1% for 12 weeks

Tazorac® Cream, 0.1% for 12 weeks

Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks

Outcomes

Primary Outcome Measures

Efficacy - total lesion counts

Secondary Outcome Measures

Safety - tolerability assessments and adverse event reporting

Full Information

NCT ID

NCT00469755

First Posted

May 2, 2007

Last Updated

July 28, 2022

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT00469755

Brief Title

Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne

Official Title

A Comparison of Differin® Gel, 0.1% vs. Tazorac® Cream, 0.1% vs. Differin® Gel, 0.1% 6-week Treatment Switched to Tazorac® Cream, 0.1% 6-week Treatment in Patients With Acne Vulgaris

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

February 2006 (undefined)

Primary Completion Date

September 2006 (Actual)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Galderma R&D

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1% compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream

Detailed Description

Same as above.

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

Phase 4

Interventional Study Model

Factorial Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

302 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Differin® Gel, 0.1% for 12 weeks

Arm Title

Arm Type

Active Comparator

Arm Description

Tazorac® Cream, 0.1% for 12 weeks

Arm Title

Arm Type

Active Comparator

Arm Description

Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks

Intervention Type

Drug

Intervention Name(s)

Adapalene Gel, 0.1%

Other Intervention Name(s)

Differin® Gel, 0.1%

Intervention Description

Apply once daily in the evening for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Tazarotene Cream, 0.1%

Other Intervention Name(s)

Tazorac® Cream, 0.1%

Intervention Description

Apply once daily in the evening for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%

Other Intervention Name(s)

Differin® Gel, 0.1% and Tazorac® Cream, 0.1%

Intervention Description

Apply adapalene Gel, 0.1% once daily in the evening for 6 weeks and Tazarotene Cream, 0.1% once daily in the evening for 6 weeks

Primary Outcome Measure Information:

Title

Efficacy - total lesion counts

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Safety - tolerability assessments and adverse event reporting

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose Exclusion Criteria: Subjects with more than 3 nodulo-cystic lesions

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald W Gottschalk, MD

Organizational Affiliation

Galderma R&D

Official's Role

Study Director

Facility Information:

Facility Name

Therapeutics Clinical Research

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Henry Ford Medical Center-Dept. of Dermatology

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Minnesota Clinical Study Center

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

State University of New York Downstate Medical Center-Dept. of Dermatology

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11203

Country

United States

Facility Name

Dermatology Research Associates

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45230

Country

United States

Facility Name

Phoebe Rich, MD & Associates

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Milton S. Hershey Medical Center Center-Div. of Dermatology

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033-0850

Country

United States

Facility Name

DermResearch, Inc.

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

Facility Name

J & S Studies, Inc.

City

Bryan

State/Province

Texas

ZIP/Postal Code

77802

Country

United States

Facility Name

Stephens & Associates

City

Carrollton

State/Province

Texas

ZIP/Postal Code

75006

Country

United States

Facility Name

Dermatology Research Center

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

Facility Name

Virginia Clinical Research, Inc.

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne

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