Clinical Trial: Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris

This study has been completed.

Sponsors and Collaborators: KGL, Inc.
Pennsylvania State University College of Medicine, Hershey, PA
State University of New York Downstate Medical Center, Brooklyn, NY
Jefferson Medical Center, Philadelphia, PA
New York University School of Medicine, New York, NY
Allergan, Inc. Irvine, CA
Information provided by: KGL, Inc.
ClinicalTrials.gov Identifier: NCT00145106

Purpose

The purpose of the study is to compare the efficacy of three maintenance regimens (topical tazarotene, oral minocycline, or both) in sustaining improvement in acne.
Condition Intervention Phase
Acne Vulgaris
 Drug: Tazarotene 0.1% gel + placebo capsule, Oral minocycline (100 mg capsule) + vehicle gel, Tazarotene 0.1% gel + oral minocycline (100 mg capsule)
Phase IV

MedlinePlus related topics:  Acne

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: Regimen of Tazorac .1% Gel & Minocycline Cap in Tx of Individuals w/Acne Vulgaris: Effects of Maintenance Therapy on Duration of Improvement of Tazorac .1% Gel Used in Conjunction w/Placebo Cap Compared w/Minocycline Cap Used in Conjunction w/Either Tazorac .1% Gel or Vehicle Gel

Further Study Details: 
Primary Outcomes: Global improvement from baseline at week 24
Secondary Outcomes: Lesion counts at weeks 16, 20 and 24
Expected Total Enrollment:  189

Study start: March 2002;  Study completion: March 2005
Last follow-up: August 2002;  Data entry closure: December 2002

For many years antibiotic therapy has been the backbone of therapy for inflammatory acne. However, topical retinoids also offer efficacy against inflammatory acne and the combination of a topical retinoid and an antibiotic can result in faster and more complete clearing of inflaamatory lesions than either drug alone.

The reduced sensitivity of Propionibacterium acnes to antibiotics is a growing problem. Resistance is a major issue not only because it can result in treatment failure but also because of concerns that it may potentially be transferred to other bacteria that anti-acne antibiotics are used used against. One of the most important factors predisposing to the development of resistant strains of propionibacterium acnes is the prolonged use of antibiotics. Therefore, in order to help minimize the development for such resistance, it is evident that maintenance strategies for acne should aim to minimize the long-term use of antibiotics.

Topical retinoids are arational choice for maintenance therapy due to their activity on microcomedones (the precursor for all acne lesions). Nevertheless, there is a paucity of data evaluating theis use in a maintenance setting. The aim of this study was to determine whether patients with moderate to severe inflammatory acne who have achieved a good level of clearance (eg>/= 75%) can maintain the improvement in their acne using maintenance therapy. THe study compared the efficacy of three maintenance therapies (topical tazarotene, oral minocycline, and topical tazarotene plus oral minocycline) in sustaining the clinical improvement attained after initial topical tazarotene plus oral minocycline therapy.

Eligibility

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Moderate facial acne vulgaris 25-60 facial inflammmatory acne lesions 10-100 facial comedos No more than 2 facial nodular cystic lesions (no more than 5 mm in diameter) For females of child bearing potential, a regular menstrual cycle Negative urine pregnancy test -

Exclusion Criteria:

Uncontrolled systemic disease Acne vulgaris known to be resisitant to antibiotics For females: pregancny, breastfeeding, or planning pregnancy Use of estrogens or birth control pills for 12 weeks or less Any skin disease that may interfere with diagnosis or evaluationof acne vulgaris Known hypersensivity to any components in Tazarac gel or to any tetracyclines Use of any systemic retinoids in past 2 years Use of any systemic antibiotics, or participation in another drug or investigational study, in past 30 days Use of topical anti-acne medication in past 14 days

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Location Information


Pennsylvania
      KGL, Inc, Broomall,  Pennsylvania,  19008,  United States

Study chairs or principal investigators

James Leyden, MD,  Principal Investigator,  KGL, Inc.   

More Information

Study ID Numbers:  T214
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00145106
Health Authority: Canada: Ethics Review Committee
ClinicalTrials.gov processed this record on 2005-09-13

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