A 6-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Ability and Safety of a Nutraceutical Supplement With Standardized Botanicals to Promote Hair Growth in Women With Self-Perceived Thinning Hair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of terminal hairs in the target area of the scalp.
研究概览
简要总结
NUTRAFOL® is a novel nutraceutical supplement, scientifically formulated to specifically target the multiple underlying causes of hair loss and thinning in women. It does not contain hormones, drugs, or industry by-products.
The purpose of this clinical research study is to evaluate the safety, efficacy and physiological effects of NUTRAFOL® supplement compared to placebo in forty (40) female subjects, ages 21-65 years of age with self-perceived thinning hair over the course of six months of continued use.
详细描述
NUTRAFOL's Synergen Complex® is a patent-pending formulation of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant and DHT-inhibiting properties - combined to synergistically combat the multiple underlying factors that compromise hair growth and health. Some patented ingredients include Sensoril Ashwagandha, BCM-95 BioCurcumin, USPlus Saw Palmetto, EVNolMax 20% Tocotrienol/Tocopherol complex, Bioperine (piperine), Cynatine HNS (solubilized keratin), and Capsimax (capsaicin), all of which are standardized and clinically tested.
Ingestion of NUTRAFOL® supplement over a six (6) month period will strengthen and promote the growth of hairs in female subjects, ages 21-65 years of age with self-perceived thinning hair when compared to using the placebo tablet. The primary endpoints will be favorable analysis using the Canon Power Shot G16 with 3GEN Dermlite FOTO Pro for macrophotography hair count analysis of terminal and vellus hairs at the three (3) month and six (6) month visits. The secondary endpoints will be favorable improvement in terminal hair diameter measured by the Dino-Lite Digital Microscopic, favorable improvement in the Hair Check device hair bundle measurement for Hair Mass Index (HMI), favorable improvement in the Blinded Physician Global Hair Assessments for hair growth and hair quality, statistically significant positive feedback on the Women's Hair Loss Quality of Life, Self-Assessment and Subject Treatment Satisfaction and Ease of Use questionnaires after six (6) months of NUTRAFOL® supplement or placebo ingestion. See Table of Study Procedures.
All patients enrolled must be identifiable throughout the study. The Investigator will maintain a personal list of patient numbers and patient names to enable records to be found at a later date and the list will be stored in a locked cabinet. Subject numbers consist of a 2 digit number from 01 to 40. Patients will be randomized to active or placebo supplements (2:1 ratio, 26 active and 14 placebo) using a randomization table prepared prior to the start of the study by a non-participating staff member at the office of the Investigator. The study blind will not be broken until the end of the study. All test product and placebo will be labeled with subject numbers per the non-participating staff member. Subjects will be assigned a subject number in numerical order as enrolled. Randomization will occur by assignment to either NUTRAFOL® supplement or placebo with 2:1 ratio (26 active and 14 placebo). Subjects who terminate their study participation for any reason, regardless of whether study medication was used or not, will retain their randomization number.
Visit Procedures: Pre-Study Procedures
- Candidate subjects will be screened with the eligibility requirements by telephone prior to Visit 1.
- Candidate subjects will be assigned an appointment time for visiting the clinic.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind study
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females, ages 21-65 years of age.
- •Clinically-determined general good health as determined by responses to the initial study assessment.
- •Females with self-perceived thinning hair as determined on initial study assessment by the Investigator (This will not include patients with medically diagnosed telogen effluvium).
- •Females willing to maintain their normal hair shampooing frequency.
- •Females willing to add the provided oral supplement to their current daily routine.
- •Females willing to not substantially change their current diet, medications, or exercise routines for the duration of the study. If a subject receives physician guidance during the study to change diet, medications, or exercise routine, the subject will need to notify the clinic as soon as possible.
- •Females willing to undergo a brief physical exam to include height, weight, blood pressure, pulse, general physical findings and a scalp exam. The physical exam will occur at Visits 1, 2 and
- •Women of child bearing potential should be willing to have a urine pregnancy test and will comply with a medically sound contraception method (including barrier control, abstinence, etc.). Women who are on birth control should have been on it for at least 6 months and willing to continue the same method of birth control. The initiation of birth control should not have been associated with the initiation of hair loss/thinning.
- •Females with Fitzpatrick I-IV photo skin types.
- •Willingness to have 2D digital photography of the entire head/hair region for overall evaluation of general hair growth and fullness at Visits 1, 2 and
- •Willingness to have digital macrophotography of the target area and scalp for hair counts at Visits 1, 2 and
- •Willingness to have a bundle of hair measured by the Hair Check device for Hair Mass Index (HMI) at Visits 1, 2 and
- •Willingness to have ten (10) terminal hairs from the target area cut at the base of the scalp for microscopic hair measurements at Visits 1, 2 and
- •Willingness to maintain a consistent hair cut and hair color throughout the 6 month study period and to come to visits with clean, dry hair.
- •Willingness of subjects who have color treated hair to have the color treatment performed at the same time interval prior to each visit (ie. If on Visit 1 the color treatment was done one week prior then the color treatment is expected to occur at a similar interval of one week prior to Visits 2 and 3).
排除标准
- •Females with any known allergy or sensitivity to any shampoo/conditioner.
- •Females who are nursing, pregnant, planning to become pregnant during the study.
- •Females with known stressful incident within the last six months (ie. death in family, miscarriage)
- •Females who are participating on any clinical research study at ASIRC or at another research center or doctor's office.
- •Females who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study (the initiation of HRT or birth control should not have been associated with the initiation of hair loss/thinning).
- •Females currently using any Low Level Laser Therapy (LLLT) to treat thinning hair.
- •Females who have regularly used Rogaine (Minoxidil) within the last 3 months.
- •Females who have used prescription drugs known to affect the hair growth cycle within the last 6 months (e.g., hormone-based birth control for less than 6 months, cyproterone acetate, aldactone/spironolactone, Finasteride or any 5-alpha-reductase inhibitor).
- •Females suffering from other hair loss disorders, such as alopecia areata, scarring alopecia, androgenetic alopecia and telogen effluvium as determined on initial study assessment by the Investigator.
- •No history of burning, flaking, itching, and stinging of the scalp.
- •History of malignancy (except scc and bcc skin cancers) or undergoing chemotherapy or radiation treatments.
- •A known history of autoimmune thyroid disease, any other thyroid disorder/abnormality or other autoimmune disorders that are not controlled in the opinion of the investigator may interfere with the study treatment.
- •A known history of depression or bi-polar disease or any other condition that may impact the subject's participation.
- •Is involved in any injury litigation claims.
- •Known history or recent blood work indicating iron deficiency, bleeding disorders or platelet dysfunction syndrome as well as subjects taking anticoagulant therapy, antiplatelet medications, more than one (1) 325 mg ASA on a daily basis or smokers with usage >20 cigarettes/day.
- •Individuals with self-reported uncontrolled diseases (i.e. diabetes, hypertension, hyperthyroidism, hypothyroidism, etc.). Medical conditions that are under control with or without treatment will be considered on an individual basis by the Investigator.
- •Females with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease.
- •Females having a known active dermatologic condition which, in the opinion of the examining Investigators, might place the subject at a greater risk or interfere with clinical evaluations (e.g., seborrheic dermatitis, psoriasis, atopic dermatitis, advanced skin cancer, etc.).
- •Use of any medications that are known to potentially cause hair loss or affect hair growth, as determined by PI.
研究组 & 干预措施
Nutrafol Supplement capsules
Subjects to take four (4) Nutrafol Supplement capsules by mouth daily for 180 days with a substantial meal
干预措施: Nutrafol Supplement capsules (Dietary Supplement)
Placebo Capsules
Subjects to take four (4) Placebo capsules by mouth daily for 180 days with a substantial meal.
干预措施: Placebo capsules (Other)
结局指标
主要结局
Number of terminal hairs in the target area of the scalp.
时间窗: 180 days
The first primary efficacy parameter from the digital macrophotographs will be the number of terminal hairs in the target area of the scalp. Terminal hair is defined as coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of greater than 40 micrometers. Digital macrophotographs will be taken of the selected target area (1 cm by 1 cm) of each subject at each visit as specified under the Schedule of Procedures. The digital macrophotographs will show the five black colored markings on the scalp that define the target area. Digital macrophotographs will be performed using a Canon Power Shot G16 with 3GEN Dermlite FOTO Pro system.The macrophotographs are then read by the investigator to determine the terminal hair count.
Number of vellus hairs in the target area of the scalp.
时间窗: 180 days
The second primary efficacy parameter from the digital macrophotographs will be the number of vellus hairs in the target area of the scalp. Vellus hair is defined as fine, short hairs found on the scalp with maximum cross-sectional diameter of 40 micrometers. Digital macrophotographs will be taken of the selected target area (1 cm by 1 cm) of each subject at each visit as specified under the Schedule of Procedures. The digital macrophotographs will show the five black colored markings on the scalp that define the target area. Digital macrophotographs will be performed using a Canon Power Shot G16 with 3GEN Dermlite FOTO Pro system. The macrophotographs are then read by the investigator to determine the vellus hair count.
次要结局
- Hair Check device hair bundle measurement for Hair Mass Index (HMI).(180 days)
- Quality of Life Questionnaire(180 days)
- General Lifestyle Questionnaire(180 days)
- Physician Global Hair Assessment(180 days)
- Self-Assessment Questionnaire(180 days)
- Dino-Lite microscopic photographs for terminal hair diameter measurements in the target area.(180 days)