A Randomized Study to Compare the Acne Relapse Rate After a 3-mo Course of Oral Minocycline, to a 3-mo Course of Oral Minocycline in Combination With a Daily Dose of Topical Tretinoin 0.01% Followed by 3 mo of Topical Tretinoin Alone
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Long-term efficacy
研究概览
简要总结
The use of oral antibiotics alone to treat inflammatory acne provides little to no long term therapeutic benefit.
Acne relapse rates can be reduced by using topical tretinoin 0.01% in conjunction with minocycline, thereby increasing the therapeutic effect of the oral antibiotic.
详细描述
Although oral antibiotics have been the mainstay of treatment of inflammatory acne for 30 years, studies comparing their efficacy have little scientific value.
Evidence-based dermatology proves minocycline to be an effective treatment for acne vulgaris while the patient remains on the medication; however, the relapse rate of acne after a course of antibiotics has never been established.
The relapse rate would appear to be significant, as repeated courses and long-term antibiotic use are commonly prescribed in practice. The increasing problem of drug resistance has raised issues of the suitability of such long term antibiotic treatment and this overuse is probably a contributing factor of multiple drug resistance in our society.
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
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of written consent
- •Either sex
- •Diagnosis of acne vulgaris with a minimum of 20 inflammatory acne lesions on the face.
排除标准
- •Known hypersensitivity to tetracyclines
- •Use of any oral antibiotics in the previous 3 months
- •Pregnancy, breast-feeding or lactating
- •Inability or unwillingness to comply with the requirements of the protocol, or agree to the use of their data as determined by the investigator.
- •Concomitant medical condition which, in the investigator's opinion, may confound the study results or interfere with study assessments or outcomes.
- •Patients with severe acne on the chest, back or trunk.
研究组 & 干预措施
Minocycline 3 mo
Minocycline 3 mo
干预措施: Minocycline (Drug)
Minocycline plus Tretinoin
Minocycline plus Tretinoin for 3 months
干预措施: Minocycline plus tretinoin (Drug)
结局指标
主要结局
Long-term efficacy
时间窗: 4 years
次要结局
- Relapse rate(4 years)
研究者
David Richard THOMAS
MD FRCP(C)
Derm Research @ 888 Inc.