NCT07839494尚未招募不适用
A Triple-blind, Randomized, Placebo-controlled, Parallel Clinical Trial to Investigate the Efficacy of BioCopper1®, Restore Cu1, and Grow + Restore Cu1 on Hair and Skin Improvements in Healthy Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Percentage of grey hair between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by HairMetrix
研究概览
简要总结
The goal of this clinical trial is to investigate the efficacy of BioCopper1®, Restore Cu1, and Grow + Restore Cu1 on grey hair, hair growth, and/or skin improvements in healthy adults. The main question it aims to answer is: what is the change from baseline to Day 168 in percentage of grey hair between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by HairMetrix? Researchers will compare the investigational products to a placebo to determine their effectiveness. Participants will be asked to:
- Have their blood pressure, heart rate, height, and weight measurements taken
- Have their blood samples collected
- Complete questionnaires and a study diary
- Be assessed using the VISIA imaging system, Corneometer, and Cutometer
- Consume BioCopper1®, Restore Cu1, Grow + Restore Cu1, or placebo
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 18 to 45 years, inclusive
- •Stable body weight defined as a <5% change in body weight in the three months prior to baseline as assessed by the Qualified Investigator (QI)
- •Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or, Individuals of child-bearing potential must have a negative baseline A urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. 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 (Nexplanon)
- •Double-barrier method
- •Intrauterine devices
- •Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
- •Vasectomy of partner at least 6 months prior to screening
- •Abstinence and agrees to use contraception if planning on becoming sexually active during the study
- •Visual confirmation of ≥ 5% and ≤ 20% of grey hair at screening
- •Pattern hair loss (Savin/Ludwig Scale Criteria I-2 (early-moderate hair loss) to II-2 (moderate hair loss) for females and Hamilton-Norwood Scale Criteria II to IV-A for males) at screening as assessed by the QI (onset of hair loss/thinning not to correspond with hormonal birth control or other recent onset of new medications, as assessed by the QI)
- •Agrees to maintain normal hair cleaning (frequency and use of non-medicated shampoo and/or conditioner) and general hair regime for the study period (including use of heated hair tools)
- •Agrees to maintain hairstyle for the study period
- •Agrees to avoid colouring hair 6 weeks prior to screening/baseline and each clinic visit
- •Agrees to maintain normal skin care routine for the study period and avoid use of cosmetic products (e.g, cleansing products, creams, makeup) on the day of clinic visits
- •Agrees to avoid excessive sun exposure and engage in safe sun practices for the duration of the study period
- •Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
- •Provided voluntary, written, informed consent to participate in the study
- •Healthy as determined by medical history and laboratory results as assessed by the QI
排除标准
- •Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- •Allergy, sensitivity, or intolerance preventing consumption of investigational product, comparator, or placebo ingredients
- •Infections or dermatological conditions of the scalp and/or face
- •Significant life or traumatic event that may be associated with acute hair loss (e.g., postpartum, job loss, death of a family member), as assessed by a QI
- •Current diagnosis or history of Lyme disease
- •History of or current diseases (e.g., alopecia areata) or conditions (e.g., trichotillomania, telogen effluvium, polycystic ovary syndrome) contributing to hair loss or thinning
- •Use of hair treatments, medications, or therapies for the purpose of regrowing and/or thickening (e.g., scalp treatments, hair transplantation surgery), as assessed by the QI
- •Individuals with hair extensions or planning on getting hair extensions during the study period, as assessed by the QI
- •Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- •Unstable metabolic disease or chronic diseases as assessed by the QI
- •Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
- •Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
- •Type I or Type II diabetes
- •Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
- •History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
- •Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- •Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- •Individuals with an autoimmune disease or are immune compromised as assessed by the QI
- •Self-reported confirmation of a Human Immunodeficiency Virus (HIV)-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
- •Self-reported confirmation of blood/bleeding disorders as assessed by the QI
- •Use of prescribed cannabinoid products as assessed by the QI
- •Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- •Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
- •Alcohol intake average of >2 standard drinks per day as assessed by the QI
- •Alcohol or drug abuse within the last 12 months
- •Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Section 7.3)
- •Clinically significant abnormal laboratory results at screening as assessed by the QI
- •Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- •Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- •Individuals who are unable to give informed consent
研究组 & 干预措施
BioCopper1
Experimental
Starting the day following their baseline B visit (Day 1), participants will be instructed to take one dose (one capsule) with water twice daily with or without food until the day prior to their end of study visit (Day 167). Participants will be instructed to not take any zinc or N-acetylcysteine supplements within 4 hours of dose.
干预措施: BioCopper1 (Dietary Supplement)
Restore Cu1
Experimental
Starting the day following their baseline B visit (Day 1), participants will be instructed to take one dose (one capsule) with water twice daily with or without food until the day prior to their end of study visit (Day 167). Participants will be instructed to not take any zinc or N-acetylcysteine supplements within 4 hours of dose.
干预措施: Restore Cu1 (Dietary Supplement)
Grow + Restore Cu1
Experimental
Starting the day following their baseline B visit (Day 1), participants will be instructed to take one dose (one capsule) with water twice daily with or without food until the day prior to their end of study visit (Day 167). Participants will be instructed to not take any zinc or N-acetylcysteine supplements within 4 hours of dose.
干预措施: Grow + Restore Cu1 (Dietary Supplement)
Placebo
Placebo Comparator
Starting the day following their baseline B visit (Day 1), participants will be instructed to take one dose (one capsule) with water twice daily with or without food until the day prior to their end of study visit (Day 167). Participants will be instructed to not take any zinc or N-acetylcysteine supplements within 4 hours of dose.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Percentage of grey hair between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by HairMetrix
时间窗: Visit 1 (day -4) to visit 5 (day 168)
Change from baseline to Day 168 in percentage of grey hair between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by HairMetrix.
次要结局
- Change from baseline to Day 84 in percentage of grey hair between BioCopper1®, Restore Cu1, or Grow + Restore Cu1and placebo, as assessed by HairMetrix(Visit 1 (day -4) to visit 3 (day 84))
- Change from baseline to Day 87 in hair growth and density between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by ratio of vellus to terminal hairs(Visit 1 (day -4) to day 87)
- Change from baseline to Day 87 in hair growth and density between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by hair density(Visit 1 (day -4) to day 87)
- Change from baseline to Day 87 in hair growth and density between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by hair fiber diameter(Visit 1 (day -4) to day 87)
- Change from baseline to Day 87 in hair growth and density between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by percentage of hairs in the anagen phase(Visit 1 (day -4) to day 87)
- Change from baseline to Day 87 in hair growth and density between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by percentage of hairs in the telogen phase(Visit 1 (day -4) to day 87)
- Change from baseline to Day 84 between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo as assessed by Corneometer and Cutometer(Visit 1 (day -4) to day 84)
- Change from baseline to Day 84 between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo as assessed by VISIA(Visit 1 (day -4) to day 84)
- Difference in perceived skin and hair improvements at Day 84 and Day 168 between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo(Day 84 and Day 168)
- Change from baseline to Day 84 and Day 168 in energy/fatigue and sleep between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo(Visit 1 (day -4) to day 84 and day 168)
研究者
研究点 (1)
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