Clinical Evaluation of a Nonablative Fractional 1940 nm Diode Laser for Treatment of Pigmented Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pigmented Lesion Improvement by Blinded Evaluation
研究概览
简要总结
This study is being conducted to evaluate the safety and efficacy of a fractional diode laser for treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots), and ephelides (freckles).
详细描述
Prospective, open-label, clinical trial to study the effects of the nonablative, fractional diode laser for treatment of pigmented lesions.
Up to 60 eligible participants will be enrolled at up to five (5) sites. Participants will receive up to three (3) treatments in the following treatment areas: face, hands, arms, back, chest, or legs. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final study 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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •Age 21 to 70
- •Fitzpatrick Skin Type I to VI
- •Willingness to have test spots and up to three (3) treatments for pigmented lesions on or off the face which are rated at baseline as moderate or higher per Investigator or study staff
- •Provide signed informed consent to participate in the study
- •Adhere to study treatment and follow-up schedules
- •Willing to have hair removed from the intended treatment area prior to treatment and/or photography
- •Avoid sun exposure to all treated areas and use of sunscreen with sun protection factor (SPF) 30 or greater throughout the duration of the study
- •Adhere to post-treatment care instructions
- •Allow photography of treated areas and to release their use for scientific and/or promotional purposes
排除标准
- •Pregnant, planning to become pregnant, or breast feeding during the study
- •Allergy to lidocaine or similar medications
- •Excessively tanned skin in the intended treatment area
- •Open wound or infection in the intended treatment area
- •Tattoo(s) or permanent make-up in the intended treatment area
- •Skin condition in the intended treatment area that could interfere with treatment or evaluation of safety or efficacy
- •Presence or history of melasma
- •Presence or history of skin cancer within the treatment area
- •History of keloid or hypertrophic scar formation
- •History of herpes simplex virus (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
- •Diagnosed coagulation disorder
- •Immunosuppression disorder
- •Presence of any medical condition that in the opinion of the Investigator could impair healing or outcome as a result of treatment
- •Use of systemic retinoid therapy (e.g. Accutane) during the past six (6) months
- •Use of topical retinoid therapy in the intended treatment area during the past two (2) weeks
- •Use of oral corticosteroid therapy during the past four (4) weeks
- •Prior treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past three (3) months
- •Prior injectable dermal fillers (e.g. collagen, hyaluronic acid) in the intended treatment area within the past 12 months
- •Prior injectable toxins (e.g. Botox) in the intended treatment area within the past three (3) months
- •Subjects who in the opinion of the Investigator are unwilling or unable to adhere to the study requirements, or who are otherwise not a good candidate for the study
结局指标
主要结局
Pigmented Lesion Improvement by Blinded Evaluation
时间窗: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
The primary efficacy endpoint was defined as improvement in the clearance of pigmented lesions, as assessed by three (3) blinded evaluators comparing photographs taken at Baseline/Pre-treatment and at the 1-month follow-up (post final treatment)
次要结局
- Pigmentation Improvement at the 3-month Follow-up, by Blinded Evaluation(3-months post final treatment, where treatment series could last up to 10 weeks after baseline)
- Subject Satisfaction With Treatment Results(1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline)
- Blinded Assessment of Textural Improvement Using a 5-point Global Aesthetic Improvement Scale (GAIS)(1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline)
- Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS)(1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline)