Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris
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|ClinicalTrials.gov Identifier: NCT00145106|
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : December 15, 2005
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||189 participants|
|Intervention Model:||Parallel Assignment|
|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|
- Global improvement from baseline at week 24
- Lesion counts at weeks 16, 20 and 24
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 ClinicalTrials.gov identifier (NCT number): NCT00145106
|United States, Pennsylvania|
|Broomall, Pennsylvania, United States, 19008|
|Principal Investigator:||James Leyden, MD||KGL, Inc.|