NCT01662349终止不适用
A Single Center, Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Plasma Treatment System in Treating Back Acne
Moe Medical Devices2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2012年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in number of reported adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety of treating human skin with atmospheric plasma and get an initial evaluation of the efficacy of this treatment for acne.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-pregnant, non-nursing females age 18-40 years old.
- •Presence of clinically-evident back acne.
- •Minimum of 20 non-inflammatory lesions (open and closed comedones)
- •Minimum of 30 total lesions (sum of inflammatory and non-inflammatory)
- •Subject must have measurable sebum production.
- •Subjects must be in generally good health.
- •Must be able and willing to comply with the requirements of the protocol.
排除标准
- •Any nodulo-cystic lesions at Baseline
- •Pregnancy or breast feeding
- •Use of acne devices or systemic therapy with antibiotics within four months prior to start and throughout the duration of the study
- •Intake of any oral retinoids within four months prior to study start and throughout the duration of the study
- •Topical use of topical retinoids within two weeks prior to study start and throughout the duration of the study
- •Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study
- •Use of an experimental drug or device within 30 days prior to study start;
- •Intake of hormonal therapy within 3 months prior to study start
- •Use of topical products on the back containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.
- •Concomitant use of mega-doses of certain vitamins, such as vitamin D (>2000IU QD) vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
- •Procedures on the skin of the back such as chemical or laser peel, microdermabrasion, photodynamic therapy) within the past 2 weeks or during the study.
- •History or evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication
- •Any significant medical conditions that could confound the interpretation of the study results.
- •History of/or current skin cancer cancer
- •Use of tanning booths, sun lamps within the past 2 weeks or during the study
- •Any metallic implants or prostheses in the vicinity of the treatment site (such as shoulders, back, spine, pacemakers, etc.).
- •Any known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.
- •History of significant post-inflammatory hyperpigmentation at the sites of acne lesions.
- •History of or is currently immunocompromised.
研究组 & 干预措施
Plasma
Experimental
Plasma applied to back for up to 20 minutes, twice/week for 4 weeks
干预措施: MOE Antimicrobial Plasma Treatment System (Device)
结局指标
主要结局
Change in number of reported adverse events
时间窗: Change from Baseline to 1 month post-treatment
次要结局
未报告次要终点
研究者
研究点 (2)
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