NCT03106792已完成2 期
A Randomized, Double-blind, Placebo-controlled, 4-arm Parallel Study to Evaluate the Effectiveness of Hairfinity on Improving Hair Health and Rate of Growth
Brock Beauty Inc.1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2017年7月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Rate of distal hair growth
研究概览
简要总结
The primary outcome of the study is the effect of Hairfinity vs. Placebo on the rate of distal hair growth, assessed using Trichoscan HD, in healthy female adults from baseline to day 90 (end of study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female 18-50 years of age (inclusive)
- •Subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).
- •Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
- •Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- •Intrauterine devices
- •Vasectomy of partner
- •Double Barrier Method
- •Non-heterosexual lifestyle
- •Fitzpatrick skin type of I-V (See appendix 3)
- •Willing to maintain the colour of and style of the hair cut for the duration of the study
- •Willing to maintain shampooing frequency and general hair regime for the duration of the study
- •Willing to not cut hair for the duration of the study
- •Willing to have area of hair prepped for Trichoscan analysis
- •Healthy as determined by laboratory results, medical history, and physical exam
- •Subjects must agree to comply with study procedures
- •Has given voluntary, written, informed consent to participate in the study
排除标准
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
- •Women who have begun hormonal birth control or hormone replacement within 6 months of randomization
- •Subjects taking natural health products, including multi-vitamins, botanicals and other nutraceuticals, within 2 weeks of randomization and for the duration of the study
- •Subjects with Fitzpatrick scores over V, which stems from the sensitivity of the testing method (requires a degree of color contrast when evaluating hair relative to skin)
- •Subjects having underwent a form of treatment for thinning hair, including prescription drugs or light therapy within 6 months of randomization
- •Medical history of diagnosed alopecia and/or trichotillomania (compulsive hair pulling). Medical history may be assessed by the Qualified Investigator
- •Subjects currently using hair extensions
- •Subjects with psoriasis or any active dermatological condition of the scalp at randomization that in the opinion of the qualified investigator would interfere with the clinical evaluations
- •Medical history of thyroid disorders or with TSH levels outside the normal range (0.4-4.5 ±0.05) as assessed by the Qualified Investigator
- •Unstable medical condition as determined by qualified investigator
- •Clinically significant abnormal lab results at screening will be assessed by the Qualified Investigator
- •History, or current diagnosis of any cancer (except for successfully treated basal cell carcinoma in an area other than the scalp) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years of diagnosis are acceptable.
- •Alcohol abuse or drug abuse within the past 6 months
- •Consumption of greater than 2 standard alcoholic drinks per day
- •Use of medicinal marijuana
- •Participation in a clinical research trial within 30 days prior to randomization
- •Allergy or sensitivity to study product and/or it's ingredients
- •Individuals who are cognitively impaired and/or who are unable to give informed consent
- •Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject (e.g. cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders etc)
研究组 & 干预措施
Hairfinity #1
Experimental
Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days
干预措施: Hairfinity #1 (Dietary Supplement)
Hairfinity #2
Experimental
Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days
干预措施: Hairfinity #2 (Dietary Supplement)
Hairfinity #3
Experimental
Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days
干预措施: Hairfinity #3 (Dietary Supplement)
Placebo
Placebo Comparator
Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Rate of distal hair growth
时间窗: 90 days
assessed using Trichoscan HD
次要结局
- Changes in hair quality(90 days)
- Change in mean diameter of hair fibers(90 days)
- Change in hair density(90 days)
- Change in the number of terminal and vellus hairs(90 days)
- Changes in the percent of hairs in the anagen and telogen phases(90 days)
- Changes in hair quality parameters(90 days)
- Change in number of shed hair strands(90 days)
研究者
研究点 (1)
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