NCT01149876已完成4 期
A Single Blind, Placebo Controlled Trial to Evaluate Effects of a Study Medication, a Nu Skin Lightening Product With and Without Iontophoresis vs Tretinoin Cream vs Vehicle Control for Facial Hyperpigmentation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Hyperpigmentation of the Face
研究概览
简要总结
The purpose of this study is to determine whether a topical Nu Skin product with or without a galvanic spa device improves brown spots on the face. The Nu Skin product will be compared to an over the counter moisturizer and tretinoin cream.
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
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able to understand and sign informed consent.
- •Able to complete study and comply with study procedures.
- •Caucasian female ages 25-
- •Presence of photodamage and lentigines of II-III on the Glogau Photoaging
- •Must be willing to avoid laser and light treatments, treatments with filler, chemical peels, microdermabrasion, Botox or any other cosmetic treatment to the face during the duration of the study.
- •Must be willing to avoid changing topical moisturizers and cosmetics during the study.
- •Able to stop any alpha or beta hydroxy acids, topical retinol or retinoid derivatives, topical antioxidants, or any topical product that may interfere with the study 2 weeks prior to the study.
排除标准
- •Cosmetic treatment of face, such as laser or light treatment, filler, Botox, microdermabrasion, or chemical peels 6 months prior to study or during study.
- •Current smoker.
- •Pregnant, nursing, or planning to become pregnant during study.
- •Currently taking drugs including oral retinoids or any other medication with a known clinically significant drug interaction with topical tretinoin.
- •Known hypersensitivity to retinoids. History of severe retinoid dermatitis.
- •History of substance abuse, mental dysfunction, or other factors limiting ability to cooperate with study.
- •Concurrent participation in another clinical study or participation 30 days prior to enrollment that includes exposure to an investigational drug that would interfere with this study.
- •Any disease or condition which would interfere with study participation or unduly increase risk.
- •Presence of an electrically sensitive support system such as a pacemaker.
- •Known history of epilepsy.
- •Presence of metal implants or metal braces on teeth.
研究组 & 干预措施
Nu Skin product with galvanic spa system
Experimental
干预措施: Cosmetic instrument (Other)
Nu Skin Product
Experimental
干预措施: Nu Skin Product (Other)
Nu Skin product with galvanic spa system
Experimental
干预措施: Nu Skin Product (Other)
Tretinoin cream 0.05
Active Comparator
干预措施: Tretinoin cream 0.05 (Drug)
over the counter moisturizer
Placebo Comparator
干预措施: CeraVe moisturizer (Other)
结局指标
主要结局
Change in Hyperpigmentation of the Face
时间窗: baseline to 16 weeks
Primary outcome measure will be change in hyperpigmentation of baseline compared to week 16. Hyperpigmentation will be measured clinically using a 0-6 scale where 0 is no hyperpigmentation and 6 is very severe hyperpigmentation.
次要结局
- Change in Rhytides(baseline to week 16)
研究者
Molly A. Wanner, MD
Assistant Physician, Dermatology
Massachusetts General Hospital
研究点 (1)
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