Microdermabrasion for Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Counts of specific types of acne lesions.
研究概览
简要总结
The purpose of this research project is to study the effect of micordermabrasion to try to improve the appearance of facial acne. The microdermabrasion machine is a hand-held device that directs pressurized aluminum oxide crystals at its target accompanied by a suction device. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin's response causes these improvements. In this study, we are interested in learning how well microdermabrasion works to improve the symptoms of acne.
详细描述
Acne vulgaris remains among the most common cutaneous disorders, impacting the vast majority of people at some point during their lives. It is associated with significant psychosocial morbidity, and there remains the need for efficacious and low risk therapeutic options.
Microdermabrasion is a technique combining abrasion and negative pressure used primarily in the treatment of aging skin. It has also been proposed to improve acne presumably through a comedolytic effect. Negative pressure and abrasion may remove debris from follicular orifices that act as a nidus for acne lesions. Many physicians and spas use micordermabrasion as a treatment for acne, however, there has never been a randomized controlled trial to substantiate this practice.
We propose to evaluate the efficacy of microdermabrasion in the treatment of inflammatory acne. We will use the Bellamed microdermabrasion system produced by Bella products or the Altair Diamondtome System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13 years or older of either gender and of any racial/ethnic group.
- •Presence of clinically evident acne vulgaris of the facial skin.
- •Subjects must be in generally good health.
- •Subjects must be able and willing to comply with the requirements of the protocol.
- •Subjects must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.
排除标准
- •Oral retinoid use within 6 months of entry into the study.
- •Systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study.
- •Topical acne therapies (retinoids,antibiotics) within 2 weeks of entry into the study.
- •Laser or superficial chemical peels at the sites to be treated within 3 months of entry into the study.
- •Subjects with a history of dermabrasion or laser resurfacing at the sites to be treated.
- •Use of topical lipid absorbing substances (Clinac AC) within 2 weeks of entry into the study.
- •Non-compliant subjects.
- •Subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation.
- •Subjects using alcohol-based topical solutions or "exfoliating" agents within 2 weeks of entry into the study.
- •Subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
- •Pregnant or nursing females.
结局指标
主要结局
Counts of specific types of acne lesions.
时间窗: These lesions will be counted at baseline, at follow-up evaluation visits during the treatment series, and every 1-4 weeks following the final treatment for a total of up to 18 weeks.
次要结局
- Clinical photographs(Photographs may be obtained at baseline, at follow-up evaluation visits during the treatment series, and every 1-4 weeks following the final treatment for a total of up to 18 weeks.)
- Subject self-assessment questionnaire(At end of treatment phase.)