Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro/ GentleMax Pro Plus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Treatment Time
研究概览
简要总结
Demonstrate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended uses: hair removal including pseudofolliculitis barbae (PFB), clearance of pigmented and/or vascular lesions, temporary increase of clear nail in patients with onychomycosis and improvement in appearance of wrinkles. Evaluate GentleMax Pro Plus™ laser system for the clearance of 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age or older
- •Willingness to provide signed, informed consent to participate in the study
- •Presence of unwanted hair, moderate or greater benign pigmented lesions, active acne, vascular lesions, nails affected with onychomycosis, and/or wrinkles assessed as Fitzpatrick Wrinkle and Elastosis Score (FWS) >/= 1
- •Willingness to adhere to study treatment and follow-up schedule
- •Willingness to adhere to post-treatment care instructions
- •Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
- •Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study
排除标准
- •Pregnant, planning pregnancy during the study, or breast feeding
- •Blonde, grey, or white hair in subjects seeking hair removal
- •Tattooed skin in the intended treatment area
- •Active sun tan in the intended treatment area
- •History of active Herpes Virus Simplex (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
- •History of melanoma
- •History of vitiligo in the intended treatment area
- •History of keloid or hypertrophic scar formation
- •History of Melasma in the intended treatment area or per Investigator's discretion
- •Severe immunosuppression resulting from medications and/or a medical condition that could impair healing after treatment
- •Open wound or infection in the intended treatment area
- •History of light induced seizure disorders
- •The subject is not suitable, in the opinion of the Investigator, for participation in the study due to inability to adhere to the study requirements, medical, or other reasons that could compromise the study integrity or subject safety
- •Dermatologic and/or cosmetic procedures including use of medications, or topicals in the intended treatment area(s) during a timepoint prior to the study that the investigator deems the subject unsuitable for the study
结局指标
主要结局
Treatment Time
时间窗: 8 Months
Evaluate the speed (time of treatment completion) with larger spot sizes for hair removal
Hair Count Assessments
时间窗: 14 Months
Improvement in hair clearance quantified by hair counts taken within a portion of the treatment area and percent reduction by assessments of digital photos taken at Baseline compared to follow-ups.
Global Aesthetic Improvement Score
时间窗: 7 Months
Improvement in the appearance of wrinkles, benign pigmented lesions, and/or vascular lesions from baseline to follow-up(s) via the Investigator Global Aesthetic Improvement Score (IGAIS) whereas 1 = very much improved and 5 = worse. A lower score post treatment(s) indicates a better outcome.
Acne Counts
时间窗: 5 Months
Measured by improvement of acne counts from baseline compared to follow-ups. A lower score post treatment(s) indicates a better outcome.
Pigment Improvement Score
时间窗: 7 Months
Improvement in BPLs from baseline to follow-ups via the Investigator Pigment Improvement Score (PIS) whereas 0 = no improvement and 4 = excellent response. A higher score post treatment(s) indicates a better outcome.
Fitzpatrick Wrinkle and Elastosis Score
时间窗: 7 Months
Improvement in the appearance of wrinkles from baseline to follow-up(s) via the Investigator Fitzpatrick Wrinkle and Elastosis Scale whereas 1 = fine wrinkles and mild elastosis and 9 = deep wrinkles and severe elastosis. A lower score post treatment(s) indicates a better outcome.
Onychomycosis Score
时间窗: 9 Months
Improvement in the appearance of nails from Baseline to follow-up(s) via the Scoring Clinical Index of Onychomycosis (SCIO Index) which ranges from 0 to 30 whereas 0 indicates lesser degree of onychomycosis and 30 indicates higher degree of onychomycosis. A lower score post treatment(s) indicates a better outcome.
次要结局
- Subject Global Aesthetic Improvement Score(24 Months)
- Subject Pain(8 Months)
- Subject Satisfaction Score(24 Months)