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Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00145106
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : December 15, 2005
Milton S. Hershey Medical Center
State University of New York - Downstate Medical Center
Jefferson Medical College of Thomas Jefferson University
NYU Langone Health
Information provided by:
KGL, Inc.

Brief Summary:
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 or disease Intervention/treatment 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 4

Detailed Description:

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 inflammatory 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 a rational choice for maintenance therapy due to their activity on microcomedones (the precursor for all acne lesions). Nevertheless, there is a paucity of data evaluating this 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : March 2002
Study Completion Date : August 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Primary Outcome Measures :
  1. Global improvement from baseline at week 24

Secondary Outcome Measures :
  1. Lesion counts at weeks 16, 20 and 24

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Moderate facial acne vulgaris 25-60 facial inflammatory 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 resistant to antibiotics For females: pregnancy, 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 evaluation of 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00145106

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United States, Pennsylvania
KGL, Inc
Broomall, Pennsylvania, United States, 19008
Sponsors and Collaborators
KGL, Inc.
Milton S. Hershey Medical Center
State University of New York - Downstate Medical Center
Jefferson Medical College of Thomas Jefferson University
NYU Langone Health
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Principal Investigator: James Leyden, MD KGL, Inc.
Layout table for additonal information Identifier: NCT00145106    
Other Study ID Numbers: T214
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: December 15, 2005
Last Verified: September 2005
Keywords provided by KGL, Inc.:
acne, tazarotene, minocycline, maintenance, retinoid, efficacy, combination
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Dermatologic Agents
Keratolytic Agents