NCT01257555已完成不适用
Evaluation of a Photopneumatic System for the Treatment of Acne
Solta Medical1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of a photopneumatic therapy for the treatment of acne and concomitant symptoms associated with the disease, including erythema.
详细描述
The primary aims of the study will be to demonstrate the safety and efficacy of using a photopneumatic system for treatment of mild to moderate acne on the face or body - including neck, chest, and back - of up to 24 subjects. To support this clinical assessment, the affected areas to be treated will be documented at baseline, at each subsequent treatment visit (up to 6 treatments), and at one (1) month and three (3) months following final treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fitzpatrick skin type I-VI.
- •Male or female.
- •Subjects must be between 18 and 55 years of age.
- •Subjects must have mild to moderate acne (defined as 15 or more inflammatory or non-inflammatory lesions).
- •Subjects must read, understand, and sign the informed consent form.
- •Subjects must be willing and able to comply with all follow-up requirements.
排除标准
- •Subjects must not have active localized or systemic infections.
- •Subjects must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid scar formation), atrophic dermatitis or immunologic abnormalities such as vitiligo.
- •Subjects must not have received microdermabrasion within one (1) month prior to enrollment.
- •Subjects must not have received immunosuppressive medication(s) one (1) month prior to enrollment.
- •Subjects must not have received laser or light treatment within the last three (3) months.
- •Subjects must not have received dermabrasion, TCA peel greater than 20%, botulinum toxin type A, dermal fillers, photodynamic therapy (PDT), or cosmetic surgery within the last six (6) months .
- •Subjects must not be currently taking or have used isotretinoin (e.g. Accutane) within six (6) months prior to enrollment.
- •Subjects must agree to refrain from using cosmeceutical agents or topical agents during the course of the study, except as directed by study investigators.
- •Subjects must not have had previous ablative laser treatment.
- •Subjects must refrain from excessive sun exposure during participation in this study.
- •Subjects must not have any condition that results in photosensitivity or be taking any medication containing aminolevulinic acid (E.g. Levulan).
- •Subjects must not be a current or past smoker of cigarettes and/or cigars.
- •Subjects must not be pregnant.
- •Any condition or situation that would prevent the subject from safely completing all protocol requirements for participation.
研究者
研究点 (1)
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