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Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris

NCT ID: NCT00829049

Last Updated: 2012-09-12

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-10-31

Brief Summary

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Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris

Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Tazarotene Cream 0.1%

1 pea-size amount, QD x 16 weeks

Group Type ACTIVE_COMPARATOR

Tazarotene Cream 0.1%

Intervention Type DRUG

1 pea-size amount, QD x 16 weeks

Adapalene Gel 0.3%

1 pea-size amount, QD x 16 weeks

Group Type ACTIVE_COMPARATOR

Adapalene

Intervention Type DRUG

1 pea-size amount, QD x 16 weeks

Interventions

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Tazarotene Cream 0.1%

1 pea-size amount, QD x 16 weeks

Intervention Type DRUG

Adapalene

1 pea-size amount, QD x 16 weeks

Intervention Type DRUG

Other Intervention Names

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TAZORAC® Cream 0.1% Differin® Gel 0.3%

Eligibility Criteria

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Inclusion Criteria

* Facial acne vulgaris characterized by the following: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater).
* Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study.

Exclusion Criteria

* Non-compliance with washout period
* Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris
* Allergy or sensitivity to any component of the test medications
* Cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Fremont, California, United States

Site Status

Countries

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United States

Other Identifiers

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MA-TAZ0702

Identifier Type: -

Identifier Source: org_study_id