NCT02635880已完成不适用
A Clinical Evaluation of a Novel Multi-Wavelength Laser for Benign Pigmented Lesion Removal
Cutera Inc.2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年9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
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Change of Treated Lesions
研究概览
简要总结
To evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM laser that offers multiple wavelengths for removal of benign pigmented lesions.
详细描述
The purpose of this investigation is to evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM laser for benign pigmented lesion (BPL) removal. Currently, the enlightenTM laser offers two wavelengths: 532nm KTP and 1064nm Nd:YAG. The version of the laser under investigation allows the user to choose from a range of wavelengths.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or Male, 18 to 65 years of age (inclusive).
- •Fitzpatrick Skin Type I - III (Appendix 3).
- •Clinical diagnosis of benign pigmented lesions located on the hand, body or face.
- •Presence of 5 or more benign pigmented lesions in the treatment area, ranging in diameter from 2 to 8 mm.
- •Has not used any prescription or over-the-counter topical creams (such as hydroquinone, retinoids or corticosteroids) in the designated treatment area within 4 weeks of enrollment in the study and is willing to refrain from use for the duration of the study.
- •Subject must be able to read, understand and sign the Informed Consent Form.
- •Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
- •Wiling to cover treated area or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area starting 2 to 4 weeks before the treatment and every day for the duration of the study, including the follow-up period.
- •Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
- •Agree to not undergo any other procedure(s) for the treatment of BPL during the study.
- •Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study.
排除标准
- •Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- •Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as chemical peel, laser or light-based procedure, or surgery.
- •Presence of pre-malignant or malignant lesion in the treatment area (such as, but not limited to pigmented actinic keratosis, lentigo maligna or lentigo maligna melanoma) or history of a pre-malignant or malignant lesion in the treatment area.
- •Shows signs of actinic bronzing and/or excessively tanned in areas to be treated, and unable or unlikely to refrain from tanning during the study (for example, subject's occupation requires regular sun exposure).
- •Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
- •Pregnant and/or breastfeeding.
- •Having an infection, dermatitis or a rash in the treatment area.
- •Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
- •Suffering from coagulation disorders or taking prescription anticoagulation medications.
- •History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- •History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- •History of vitiligo, eczema, or psoriasis.
- •History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- •History of seizure disorders due to light.
- •Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
- •History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen
- •History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
- •History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- •Systemic use of corticosteroid or isotretinoin within 12 months of study participation.
- •Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
- •Current smoker or history of smoking within 6 months of study participation.
- •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
研究组 & 干预措施
Investigational Enlighten Device
Experimental
Laser treatment for removal of benign pigmented lesions (BPLs) with Nd:YAG dual-wavelength, dual-pulse duration laser.
干预措施: Investigational Enlighten Device (Device)
结局指标
主要结局
Percentage of Participants With Change of Treated Lesions
时间窗: Baseline and 6 weeks post-final treatment
Degree of change in treated lesions at 6 weeks post-final treatment as assessed using the Global Aesthetic Improvement Scale (GAIS) with a scoring of 0 - for no change, 1 - Mild Improvement, 2 - Moderate Improvement, 3 - Significant Improvement, 4 - Very SIgnificant Improvement.
次要结局
- Percentage of Particpant Satisfaction of Improvement in Treated Lesions by the Subject(6 weeks post-final treatment)
研究者
研究点 (2)
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