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Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris

NCT ID: NCT00834210

Last Updated: 2011-10-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-09-30

Brief Summary

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A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tazarotene cream 0.1% compared with tazarotene cream 0.1% monotherapy 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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1

Dapsone Gel 5% and Tazarotene Cream 0.1%

Group Type ACTIVE_COMPARATOR

Dapsone

Intervention Type DRUG

Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks

2

Tazarotene Cream 0.1%

Group Type ACTIVE_COMPARATOR

Tazarotene

Intervention Type DRUG

Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks

Interventions

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Dapsone

Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks

Intervention Type DRUG

Tazarotene

Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks

Intervention Type DRUG

Other Intervention Names

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Aczone Gel 5%; Tazorac Cream 0.1% Tazorac Cream 0.1%

Eligibility Criteria

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Inclusion Criteria

* Facial acne vulgaris characterized by the following: 30-100 facial inflammatory lesions; and 25-100 facial non-inflammatory lesions; stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or more nodules and/or cysts (diameter of 1cm or greater). Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study

Exclusion Criteria

* Non-compliance with washout period; history of clinically significant anemia or hemolysis; skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris; allergy or sensitivity to any component of the test medications
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-ACZ0802

Identifier Type: -

Identifier Source: org_study_id