NCT04599751已完成不适用
The Safety and Efficacy of Trio Diode Laser Module for Hair Removal Treatment in All Skin Types
Alma Lasers4 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2020年10月7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
- 37
- 试验地点
- 4
- 主要终点
- Safety- Adverse events
研究概览
简要总结
The study is aimed to assess the safety and efficacy of hair removal treatments, using the Trio Laser Module (Alma Lasers).
The study will include 36 subjects that will undergo axilla and bikini line hair removal treatments. Safety and efficacy will be evaluated 3- months after the last treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to undergo hair removal treatments at the Axilla and the Bikini line.
- •Between 18 and 70 years of age.
- •Reasonably good health, as defined by the Investigator.
- •Agrees to avoid tanning during their participation in this study.
- •Agrees to shave the treatment area prior to the treatment visit, according to the investigator's instructions.
- •Subjects with dark brown hair.
- •Eligible for treatment following a test spot without negative effects.
- •Provided written Informed Consent and photo consent.
排除标准
- •History of laser hair removal in the treatment area.
- •Pregnant, lactating or planning to get pregnant within the study period.
- •Unwilling to use a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, if of childbearing age.
- •History of photosensitivity or use of medication with photosensitizing properties.
- •Active infection in the treatment area.
- •History or evidence of any chronic or reoccurring skin disease or disorder affecting the treatment area.
- •History of keloid scarring or hypertrophic scar formation.
- •Tattoo in the treatment area.
- •Subject has been tanning within the past 30 days.
- •History of confounding cancerous or pre-cancerous skin lesions in the treatment area.
- •History of connective, metabolic or atrophic skin disease.
- •Subject has used prohibited therapies, oral prescription medication, or topical meds (steroids) on the treatment area within 30 days prior to enrollment.
- •History of autoimmune disorder
结局指标
主要结局
Safety- Adverse events
时间窗: Through study completion, an average of 1 year
Adverse events and serious AE reported at any time during the trial or follow-up
Change in hair count
时间窗: 3 month after the last treatment
Change in hair count, preformed by blinded evaluators, based on photographs taken at 3m FU visit compared to baseline
次要结局
- Investigator's assessment of the tolerability to the treatment using a 5-point Likert scale (when "0" indicates "none" and "4" indicates "sever").(up to 24 weeks)
- Subject treatment related pain assessment, using VAS ( when "0" indicates "no pain" and "10" " worst possible pain"(up to 24 weeks)
- Subject's tolerability to the treatment, using a 5-point Likert scale (when "0" indicates "none" and "4" indicates "sever").(up to 24 weeks)
- Subject's satisfaction from the treatment, using a 5-point Likert scale (when "1" indicates very dissatisfied and "5" very satisfied)(3 months after the last treatment)
研究者
研究点 (4)
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