NCT03446079已完成不适用
Relationship of Skin Related Single Nucleotide Polymorphisms to Clinical Response to a Topical Skin Care Product
HelicalCodeMD2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2018年3月19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
- 156
- 试验地点
- 2
- 主要终点
- Genetic Profile & Product Response
研究概览
简要总结
Demonstrate the relationship between single nucleotide polymorphisms (SNP) and response to a topical skin care product.
详细描述
Cross sectional study will utilize gene-specific candidate and genome wide association analysis to identify SNP's that may be associated with response to a topical product. Investigators and patients will be blinded to the genetic test results, and participants will be blinded to the skin product applied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Investigators and participants will be blinded to the results genetic testing results during the trial duration. Only participants will be blinded to the identity of the study product.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 21 years old in general good health as determined by a health questionnaire.
- •Willingness to cooperate and participate by following study requirements and to report any adverse symptoms immediately.
- •Willingness to discontinue the use of all facial products other than the assigned test material and their regular brands of glamour products. The glamour products must be the subject's regular brand and have been used for a minimum of one month prior to the start of the study.
- •Willingness to remove make up at least 30 minutes prior to each scheduled clinic visit. No other topical products should be applied to the face until the study visit has been completed.
- •Willingness to avoid daily direct sun exposure on the face, whether natural or at tanning salons.
- •Willingness to discontinue antiaging cosmetics including alpha hydroxyacid products (including Lachydrin©), beta hydroxyacid products (including salicylic acid), poly hydroxyacid products, retinol products, acetyl glucosamine or other effective anti-aging topical products on the face 2 weeks prior to the start of the study and throughout the duration of the study.
- •Completion and signing of a Informed Consent and Enrollment form, HIPAA form, photo release form, medical intake, skin habits survey.
- •Willingness to complete all study assessments.
排除标准
- •Individuals who currently or in the last month have regularly used certain topical or oral medications which, in the opinion of the Investigators, may interfere with the study or that may expose study participants to unacceptable risks. Such products include oral prescription steroids or anti-inflammatories, topical steroids, or prescription skin treatment except for mild acne, as determined by the investigators.
- •Subjects who have a history of disease or current disease or regularly use topical or oral medications which, in the opinion of the Investigator, may interfere with the study or that may expose study participants to unacceptable risks. (i.e. oral or topical steroids or anti-inflammatories, etc.).
- •Uncontrolled metabolic disease such as diabetes, hyperthyroidism, or hypothyroidism or active Hepatitis, immune deficiency, or autoimmune disease as determined by the health questionnaire.
- •Pregnancy, nursing, or planning to become pregnant during the course of the study as determined by the health questionnaire.
- •History of skin cancer within the past 6 months.
- •Use of topical prescription retinoids for anti-aging including Retin-A®, Retin-A Micro®, Renova®, Avita®, Tazorac®, or Differin® within 2 weeks prior to the start of the study.
- •Use of oral retinoids within 6 months of the study start.
- •Subjects must not have had mid-depth or superficial chemical peel or other anti-aging procedures on the face (laser, intense pulsed light, injectable fillers microdermabrasion, etc.) within 2 months of the study start.
- •Known allergies or sensitivities to test material ingredients or any topical skin care product (i.e., alpha hydroxyacids, retinol, sunscreens, moisturizers, cleansers, masques, toners, etc.).
- •Individuals currently participating in other clinical testing.
- •Start of hormone use (including for birth control) or changed hormones less than three months prior to the start of the study. Qualified subjects must not be taking hormones or must have been taking them for at least three months prior to the study start.
结局指标
主要结局
Genetic Profile & Product Response
时间窗: 6 weeks
The primary endpoint being studied in this study is the association of the product response to the 17 candidate SNP genotypes.
次要结局
- Novel SNP Identification(6 weeks)
研究者
研究点 (2)
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