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临床试验/NCT00145106
NCT00145106已完成4 期

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

KGL, Inc.2 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2002年3月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
189
试验地点
2
主要终点
Global improvement from baseline at week 24

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Global improvement from baseline at week 24

次要结局

  • Lesion counts at weeks 16, 20 and 24

研究者

发起方
KGL, Inc.
申办方类型
Other

研究点 (2)

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