NCT01162837已完成不适用
An Evaluation of the Safety and Effectiveness of the BEAM Device in the Treatment of Mild-to-moderate Acne
Oregon Aesthetic Technologies6 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2010年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Reduction in inflammatory lesion count
研究概览
简要总结
This study will determine if the use of the BEAM device reduces the signs and symptoms of mild-to-moderate acne.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 15 years or older of either gender and of any racial/ethnic group.
- •At least 8 acne inflammatory lesions (see section 9) in the treatment and control areas.
- •Presence of clinically-evident facial acne of mild-to-moderate severity (score 2-4 on the Global Acne Severity Scale, see below)
- •Subjects must be in generally good health.
- •Subjects must be able and willing to comply with the requirements of the protocol.
排除标准
- •Oral retinoid use within six months of entry into the study.
- •Systemic acne therapies (oral antibiotics) within 2 weeks of entry into the study.
- •Topical acne therapies (retinoids, antibiotics) within 1 week of entry into the study.
- •Microdermabrasion or superficial chemical peels at the site to be treated within 2 months of entry into the study.
- •Subjects with a history of dermabrasion or laser resurfacing at the site to be treated.
- •Use of topical lipid absorbing substances (Clinac AC) within 1 week 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 1 week 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.
- •Subjects with known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.
- •Subjects who have a history of significant post-inflammatory hyperpigmentation at the sites of acne lesions.
结局指标
主要结局
Reduction in inflammatory lesion count
时间窗: 8 weeks
Reduction in the number of inflammatory acne lesions on one side of the face after 8 weeks of treatment.
次要结局
- Global Acne Severity Score(8-weeks)
研究者
研究点 (6)
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