NCT02763072已完成不适用
A Single-Center 2-Arm Study of the Enlighten and Excel V Laser for Lentigines on the Hands
Cutera Inc.2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年4月1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
- 24
- 试验地点
- 2
- 主要终点
- Percent Reduction in the Number of Hand Lentigines as Assessed by Blinded Reviewers.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of two laser systems for improvement of lentigines on the hands.
详细描述
The purpose of this study is to evaluate the effectiveness and safety in a clinic setting of two laser systems for the treatment of lentigines (liver spots, age spots, or dark sun spots) on the hands.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or Male, 30-90 years of age (inclusive).
- •Fitzpatrick Skin Type I - III.
- •Desires non-invasive and non-ablative treatment of lentigines on the hand(s).
- •Have 4 or more lentigines on the hand(s).
- •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.
- •Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area 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 treatment of lentigines during the study, including but not limited to chemical peel, laser and light based device treatment, and home-use device treatment.
- •Agree to not undergo any injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler to the treatment area during the study.
排除标准
- •Participation in a clinical trial of another device or drug in the target area 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 laser or light-based procedures or surgery.
- •Systemic use of retinoid, such as isotretinoin, within 6 months of study participation.
- •Use of topical medications on the hands, such as antibiotics, benzoyl peroxide, retinoids (isotretinoin), corticosteroids, hydroquinone, or products containing dihydroxyacetone or alpha-hydroxy with concentration > 8%, within 1 month of participation.
- •History of malignant tumors in the target area.
- •Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
- •Having an infection, dermatitis, or a rash in the treatment area.
- •History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- •Any use of medication that is known to increase sensitivity to light according to investigator's discretion.
- •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.
- •Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
- •Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- •In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systematic therapy that could interfere with this research study.
结局指标
主要结局
Percent Reduction in the Number of Hand Lentigines as Assessed by Blinded Reviewers.
时间窗: 4 weeks post-final treatment
次要结局
- Subject Satisfaction(4 weeks post final treatment)
- Physician's Global Assessment Score of Skin Texture of the Hands(4 weeks post final treatment)
- Physician's Global Assessment Score of the Overall Appearance of the Hands(4 weeks post final treatment)
研究者
研究点 (2)
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