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

NCT ID: NCT00469755

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-09-30

Brief Summary

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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

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Same as above.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Differin® Gel, 0.1% for 12 weeks

Group Type ACTIVE_COMPARATOR

Adapalene Gel, 0.1%

Intervention Type DRUG

Apply once daily in the evening for 12 weeks

2

Tazorac® Cream, 0.1% for 12 weeks

Group Type ACTIVE_COMPARATOR

Tazarotene Cream, 0.1%

Intervention Type DRUG

Apply once daily in the evening for 12 weeks

3

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

Group Type ACTIVE_COMPARATOR

Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%

Intervention Type DRUG

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

Interventions

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Adapalene Gel, 0.1%

Apply once daily in the evening for 12 weeks

Intervention Type DRUG

Tazarotene Cream, 0.1%

Apply once daily in the evening for 12 weeks

Intervention Type DRUG

Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Galderma Laboratories, L.P.

Principal Investigators

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Ronald W Gottschalk, MD

Role: STUDY_DIRECTOR

Galderma R&D

Locations

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Therapeutics Clinical Research

San Diego, California, United States

Site Status

Henry Ford Medical Center-Dept. of Dermatology

Detroit, Michigan, United States

Site Status

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Site Status

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

Brooklyn, New York, United States

Site Status

Dermatology Research Associates

Cincinnati, Ohio, United States

Site Status

Phoebe Rich, MD & Associates

Portland, Oregon, United States

Site Status

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

Hershey, Pennsylvania, United States

Site Status

DermResearch, Inc.

Austin, Texas, United States

Site Status

J & S Studies, Inc.

Bryan, Texas, United States

Site Status

Stephens & Associates

Carrollton, Texas, United States

Site Status

Dermatology Research Center

Salt Lake City, Utah, United States

Site Status

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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US10026

Identifier Type: -

Identifier Source: org_study_id

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