Hair Regrowth Efficacy of Multi-Molecular Targeting Treatment (ALRV5XR), a Randomized Controlled Clinical Trial in Women With Androgenetic Alopecia, Telogen Effluvium or Self Reported Thinning Hair: THE HAIR REBOOT TRIAL - WOMEN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- The percentage change in the terminal hair regrowth from baseline to Week 24.
研究概览
简要总结
To demonstrate that the ALRV5XR multi-molecular targeting treatment regimen of a daily shampoo, conditioner, topical serum and oral supplement is superior to placebo in promoting hair growth as assessed by change in hair density and percentage of terminal hair regrowth after ALRV5XR therapy.
This will be a single-centre, double-blind, randomized, placebo-controlled study in female subjects randomized to a 1:1 ratio of test article to placebo.
Subjects will be asked to use the study products on a daily basis for the duration of the 24-week study. Subjects will take one capsule twice daily (one in the morning and one in the evening) and will be asked to use 3-7mL of the shampoo, 3-7mL of the conditioner, and 1mL of the topical nutriment daily. Subjects will receive detailed instructions regarding the order and duration of application of each product.
Subjects in the active arm will receive active capsules, shampoo, conditioner and topical nutriment. Subjects on placebo will receive placebo capsules, shampoo, conditioner and topical nutriment. All subjects will be instructed to take the capsules orally, one in the morning and one in the evening, prior to consuming food. Shampoo and conditioner are to be used once per day when washing the hair and nutriment applied at the end of the day prior to bedtime. To facilitate this, subjects will receive a 3-month supply of each product (supplement, shampoo, conditioner, and scalp nutriment). Subjects will continue the daily regimen for 24 weeks, visiting the clinic at week 12 for an interim assessment.
详细描述
This is a prospective, randomized, double-blind, placebo-controlled, 2-arm parallel study to evaluate the efficacy and safety of a multi-molecular targeting botanical treatment regimen on parameters of hair growth, compared to placebo, in healthy female adults with androgenetic alopecia, diffuse hair loss or self-reported thinning hair.
Each study group will include 23 subjects. Subjects will be randomly assigned using computer generated randomization scheme to one of the two groups in a 1:1 ratio.
Subjects will be asked to use the study products on a daily basis for the duration of the 24-week study. Subjects will take one capsule twice daily (one in the morning and one in the evening) and will be instructed to use 3-7mL of the shampoo, 3-7mL of the conditioner, and 1mL of the topical nutriment serum daily. Subjects will receive detailed instructions regarding the order, and duration of application of each product.
This trial will be conducted at one (1) American (USA) clinical research site. The duration of the study will be approximately 28 weeks (7 months), including the screening period. There will be a screening period of up to 28 days for eligibility assessment, followed by a baseline visit followed by a 24-week experimentation period for assessment of supplement effects. There will be a total of seven visits, including a screening visit, over this 28-week period.
The study will be conducted as outlined in this protocol and in compliance with the principles of the International Conference on Harmonization (ICH) Guidelines on Good Clinical Practice (GCP) (E.6), and the Declaration of Helsinki.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study agents will have randomized codes. Supplement capsules, shampoo, conditioner and scalp serum will all be similar in look and scent to the active products. The placebo shampoo, conditioner and serum will have the same base materials as their counterparts but will not contain active ingredients, and will therefore be similar in viscosity and color.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 - 65 years of age at time of screening (V1) (inclusive).
- •Have androgenetic alopecia, diffuse hair loss or self-reported thinning or hair loss for more than 3 months prior to screening (V1).
- •Clinically confirmed to have hair loss or thinning by the investigator via physical exam.
- •In good general health, as determined by the Investigator.
- •Willing and able to attend all study visits.
- •Willing to maintain the same hair style as at the Screening Visit for the duration of the study.
- •Have a negative urine pregnancy test at screening and be using, and continue to use for the duration of the study, an effective contraception method.
- •Have Fitzpatrick skin type I-IV.
- •Be willing and able to cooperate with the requirements of the study.
- •Willingness to be photographed and provide consent for photographic release.
- •Voluntarily sign and date an informed consent approved by the Institutional Review Board.
- •Be able to complete and understand the various rating instruments in English.
- •Sponsor approved global image assessment of degree of thinning / hair loss.
排除标准
- •Clinical diagnosis of scarring forms of alopecia or alopecia areata.
- •Clinical diagnosis on the scalp of psoriasis, scaling, fungal or bacterial infection, lesions, follicular dermatitis, lice, flees or chemical burns, unusual thinning patches, traction alopecia or trichokryptomania, trichothiodystrophy, pili annulati, monilethrix or clear signs of trichodysmorphia, poor nutrition or hygiene.
- •Damage to the skin in or around the assessment areas.
- •Scalp hair loss on the treatment area, due to disease, injury, or medical therapy.
- •History of surgical correction of hair loss on the scalp - hair transplants or hair weave.
- •Are using or have used depilatories, razors, or wax on the scalp to an extent which, in the opinion of the investigator, may interfere with the performance of the study assessments
- •In the opinion of the investigator have very little contrast between hair color and scalp that would make trichometric analyses difficult.
- •Subjects who are pregnant or planning to become pregnant or are breastfeeding during the course of the study or subjects who are unwilling to use appropriate contraceptives for the duration of the study.
- •Current skin disease or conditions on the treatment area that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations.
- •Presence of major diseases such as diabetes, endocrine, cardiovascular, renal, or liver disease.
- •History of neurological disease (e.g. Parkinson's disease, stroke, traumatic brain injury, etc.).
- •History of blood clotting disorders or current use of coagulation-inhibiting medications including natural health products (e.g. warfarin, St. John's wort).
- •Recently started (<6 months) using hormone replacement therapy, including hormonal birth control. Stable dose >6 months will be permitted in the study.
- •Hypertension defined as a seated resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg or current use of blood pressure lowering medications.
- •Recently started (<6 months) using hormone replacement therapy.
- •Use of anabolic steroids or 5-alpha reductase inhibitors in 6 months prior to the baseline visit (V2).
- •Use of any products (prescription, OTC or natural health products) or devices reported and used to promote scalp hair growth (e.g., finasteride or minoxidil, L-Tyrosine) within 30 days prior to the Baseline Visit (V2).
- •Use of any medications (including natural health products) that are known to potentially cause hair loss or affect hair growth within 30 days prior to the Baseline Visit (V2), as determined by PI.
- •History of malignancy (in past 5 years) or undergoing chemotherapy or radiation treatments.
- •A known history of autoimmune disease (e.g. HIV/AIDS, systemic lupus erythematosus, inflammatory bowel disease, alopecia areata, alopecia totalis, etc.), uncontrolled thyroid disease [hyperthyroidism, hypothyroidism; controlled will be permitted if no changes in dosage are required in the 6 months prior to screening (V1)], hepatitis C, or any other disorders that in the opinion of the investigator may interfere with the study treatment.
- •Concurrent or within 3 months of baseline (V2) use of anti- inflammatory medication, corticosteroids, or immunosuppressive drugs taken for more than 2 consecutive weeks
- •Active psychiatric disease (hospitalized within the past 12 months of Screening).
- •Evidence of hepatic or renal dysfunction as evidenced by ALT or aspartate aminotransferase (AST) being ≥ 2 times the upper limit of normal or serum creatinine value ≥ 1.5X the upper limit of normal or other clinically significant abnormal clinical laboratory value, such that patient would be classified as stage 3b or greater of chronic kidney failure (eGFR below 60 ml/mjn/1.73 cm2, albumin-creatinine ratio (ACR) > 3.0 mg/mmol), under treatment for uncontrolled hypertension (HT) and other factors per PI discretion.
- •History of drug or alcohol abuse in the past 12 months prior to Screening.
- •Currently consuming more than 2 standard alcoholic beverages a day. A standard alcoholic beverage is defined as 12 ounces of beer, five (5) ounces of wine, or 1.5 ounces of liquor.
- •Have a known sensitivity or allergy to any ingredients in the test products or placebo products.
- •Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
- •Participating in or has participated in another research study within 30 days prior to screening with any investigational medical product or natural health product
结局指标
主要结局
The percentage change in the terminal hair regrowth from baseline to Week 24.
时间窗: 24 Weeks
The primary outcome will determine if the percentage change in terminal hair count from baseline to Week 24 in subjects on ALRV5XR therapy is superior to placebo, at a significance level of 5% (one tail). A two-sample t test will be used to compare differences in the mean percentage increase in total terminal hair count from baseline to Week 24 between study arms.
Change in terminal hair density from baseline to Week 24.
时间窗: 24 Weeks
The primary outcome will determine if the increase in terminal hair count per square centimeter from baseline to Week 24 in subjects on ALRV5XR therapy is superior to placebo, at a significance level of 5% (one tail). A two-sample t test will be used to compare differences in the mean increase in terminal hair count from baseline to Week 24 between study arms.
次要结局
- The percentage change in the terminal hair regrowth from baseline to Week 12.(Week 12)
- Change from baseline in hair width.(Week 12 and 24)
- Proportion of subjects achieving a ≥25% increase in hair number count(Week 12 and 24)
- Proportion of subjects achieving a ≥75% increase in hair number count(Week 12 and 24)
- Proportion of subjects achieving a ≥50% increase in hair number count(Week 12 and 24)
- Dermatology Life Quality Index (DLQI) score(Week 12 and 24)
- Proportion of subjects achieving a ≥25% increase in Severity of Alopecia Tool (SALT) scores(Week 12 and 24)
- Proportion of subjects achieving a ≥50% increase in Severity of Alopecia Tool (SALT) scores(Week 12 and 24)
- Change in terminal hair density from baseline(Week 12)
- Proportion of subjects achieving a ≥75% increase in Severity of Alopecia Tool (SALT) scores(Week 12 and 24)
- Change in anagen/telogen ratio(Week 12 and 24)
- Proportion of subjects achieving a DLQI patient global assessment score of 3 or above(Week 12 and 24)