A 3-Month, Randomized, Single-Blind, Placebo-Controlled Study Evaluating the Ability of Nutra Harmony "Biotin, Collagen &Amp;Amp; Keratin Beauty Complex" Dietary Supplement Promotion in Hair Thickness and Hair Strength in Individuals 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
- 80
- 试验地点
- 1
- 主要终点
- Hair Shedding (1-2 Hairs Per Unit)
研究概览
简要总结
The Nutra Harmony "Biotin, Collagen & Keratin Beauty Complex" is an oral food/dietary supplement specifically designed to promote hair growth for people suffering from temporary thinning hair. The hypothesis of this clinical research study is that the ingestion of "Biotin, Collagen & Keratin Beauty Complex" for over a three (3) month period will strengthen the hair and increase hair thickness by promoting the growth of terminal hairs in subjects, ages 21-50 years of age with self-perceived thinning hair associated with poor diet, stress, hormonal influences when compared to using the placebo tablet.
详细描述
This study was a two-arm, parallel group, double-blind, placebo-controlled trial powered to detect meaningful differences in the hair growth for people suffering from temporary thinning hair between the treatment(main) and control groups at 3 months. Participants of the main group were prescribed the "Biotin, Collagen & Keratin Beauty Complex" 30,000 mcg, 60 capsules produced by NUTRA HARMONY LLC, participants of the control group were prescribed placebo (microcrystalline cellulose (MCC)), 60 capsules manufactured by NUTRA HARMONY LLC. The duration of study in both groups of subjects was 3 months and the treatment period continued for 90 days following randomization. A total of 80 males and females aged 21 to 50 with temporary thinning hair who meet all eligibility criteria were randomized in this study. Within the study, there were a total of 6 site visits for each participant, during which the following procedures were performed:
Visit 1 (Screening visit):
Signing the informed consent document Demography recording Height, weight assessment Vital signs: pulse, systolic [SBP] and diastolic [DBP] blood pressure, after 10 minutes of resting position Medical history & Current medications Hematology A urine pregnancy test (for women of childbearing potential Physical examination: general/appearance; head, eyes, ears, nose, throat, and oropharynx; skin evaluations; respiratory; cardiovascular; abdomen/gastrointestinal; urological system, musculoskeletal system and neurological system High-quality clinical and dermoscopic photographs of hair in the target area of the scalp made by dermatoscope High-quality photographs of hair in the target area of the scalp made by digital camera Quality of Life Questionnaire
Visit 2 (Randomization):
Vital signs: pulse, systolic [SBP] and diastolic [DBP] blood pressure, after 10 minutes of resting position Study Intervention randomization: participants will be assigned randomly in a 1:1 ratio to study product 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
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals, ages 21-50 years of age.
- •Clinically-determined general good health as determined by responses to the initial study assessment.
- •Individuals with self-perceived thinning hair associated with poor diet, stress, hormone influences.
- •Individuals willing to maintain their normal hair shampooing frequency.
- •Individuals willing to add the provided oral supplement to their current daily routine.
- •Individuals 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.
- •Individuals willing to undergo a physical exam to include height, weight, blood pressure, pulse, general physical findings, scalp exam and blood sample collection.
- •Individuals with Fitzpatrick I-IV photo skin types.
- •Willingness to have digital photography of the target area and scalp for hair counts at Visits 1, 2, 3, 4, 5,
- •Willingness to have their hair washed (shampooed) over a sink containing cheesecloth for hair shedding counts at Visit 1, 2, 3, 4, 5,
- •Willingness to maintain a consistent haircut and hair color throughout the 3-months study period and to come to visits with clean (shampoo must be done 24 hours or more prior to the visit) and 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 (i.e. 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 Visit 2, 3 ,4 ,5, 6).
- •Provision of signed and dated informed consent form.
排除标准
- •Individuals with a known history of intolerance or allergy to fish, seafood/shellfish or acerola.
- •Individuals with any known allergy or sensitivity to any shampoo/conditioner.
- •Females who are nursing, pregnant, planning to become pregnant during the study.
- •Individuals with known stressful incident within the last six months (i.e. death in family, miscarriage).
- •Individuals who are participating on any clinical research study 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.
- •Individuals currently using light therapy to treat thinning hair.
- •Individuals who have regularly used Rogaine (Minoxidil) within the last 3 months.
- •Individuals currently using any other biotin/keratin/collagen supplements.
- •Individuals 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).
- •Individuals 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.
- •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 Investigators.
- •Individuals with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease.
- •Individuals 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.).
研究组 & 干预措施
Group Placebo
干预措施: Placebo product (Dietary Supplement)
Group Treatment
干预措施: Complex with Biotin, Collagen, Keratin, Hyaluronic Acid. (Dietary Supplement)
结局指标
主要结局
Hair Shedding (1-2 Hairs Per Unit)
时间窗: Day 90
Hair shedding was assessed by trichoscopic evaluation of the target scalp area. The endpoint reflects the proportion of participants meeting the criterion of 1-2 shed hairs per follicular unit at the specified time point.
次要结局
- Increase in the Amount of Vellus Hair Compared to Mature Hairs(90 Days)
- Increased Distance Between Units(90 Days)
- Hair Thinning(90 Days)
- Inflammatory Processes in the Scalp and Blood Vessels(90 Days)