A Randomized, Double-Blind, Placebo-Controlled, Safety, and Efficacy Study of Plant Based Biotin and Plant Based Biotin with Silica in Healthy Adult Human Subjects with Complaints of Hair Fall Thin, Dry, & Brittle Hair, and Dry Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Change in hair thickness (Unit= µm)
研究概览
简要总结
A randomized, double-blind, three-arm, placebo-controlled, safety, and efficacy study of plant-based Biotin and plant-based Biotin with Silica in healthy adult human subjects with complaints of hair fall, thin, dry, and brittle hair, and dry skin.
A sufficient number (maximum of 105 (35 subject/test treatment)) of female/male adult subjects will be recruited/enrolled to ensure a total of 96 subjects (32 subjects/test treatment) complete the study.
详细描述
The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. Total study visits will be 8 during this study.
Visit 01 (Within 30 Days): Screening procedure, Informed consent obtain process, baseline evaluations, blood collection, tattoo on scalp, hair growth rate measurement Visit 02 (Day 01): Enrolments, hair growth rate measurement, other evaluations, product distribution, diary distribution, AE reporting (if any.
Visit 03 (Day 27 +2 Days): Treatment period, evaluations, tattoo, hair growth rate measurement, diary card review, AE reporting (if any).
Visit 04 (3 Days from Visit 03): Treatment period, evaluations, diary card review, AE Reporting (if any).
Visit 05 (Day 57 + 2Days): Treatment period, evaluations, tattoo, hair growth rate measurement, diary card review, AE Reporting (if any).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
The study is double blind wherein neither the subjects nor the Investigator shall be aware of the test treatment allocation
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 20 to 60 years (both inclusive) at the time of consent
- •Sex: Healthy males and non-pregnant/non-lactating females.
- •Subject have complaints of hair fall, thin, dry and brittle hair, and dry skin.
- •Females of childbearing potential must have a reported negative pregnancy test.
- •Subject are generally in good health.
- •Subject must have negative Hepatitis B Surface Antigen Test at baseline.
- •Subject with self-proclaimed nonpathological thin, dry and brittle hair.
- •Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
- •Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
- •Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
- •Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.
- •If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- •If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
- •Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study.
- •Subjects are willing to give written informed consent and are willing to follow the study procedure.
- •Subjects who have used other marketed products for hair thinning in the past.
- •Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-thinning agents) or any other hair growth, treatment for thin hair, or hair products other than the test treatments for the entire duration of the study.
- •Willing to use test treatments throughout the study period.
排除标准
- •Subjects with a history of hair thinning/hair fall due to any clinically significant self-reported problems/s like anaemia, thyroid problems, etc.
- •Subject has a history of allergy or sensitivity to the test treatment ingredients.
- •Subject has a history of any dermatological condition of the scalp other than hair loss and/or dandruff or active dermatological condition that might interfere with the clinical assessments (e.g. tattoos, eczema, psoriasis, acne, etc.).
- •Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
- •Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
- •Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
- •Subject is currently pregnant/breastfeeding.
- •Subject has a history of prior use of hair growth treatment within 3 months.
- •Subject has a history of any prior hair growth procedures (e.g., hair transplant or laser).
- •Subject has a history of alcohol or drug addiction.
- •Subjects who have plans of shaving scalp hair during the study.
- •Subject has a past or present condition of irritated or visibly inflamed scalp or severe scalp disease.
- •Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
- •Pregnant or breastfeeding or planning to become pregnant during the study period.
- •History of chronic illness which may influence the cutaneous state.
- •Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials or hair/scalp/skin care products within the last four weeks.
结局指标
主要结局
Change in hair thickness (Unit= µm)
时间窗: From baseline (Day 01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo arm
To assess the effectiveness of test treatment in terms of change in hair thickness by CASALite Nova thorough Phototrichogram
Change in PGA score for sign of Peeling
时间窗: From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface peeling by using 4 point scoring scale where 0= none, 3= severe
Change in hair fall
时间窗: Baseline (Day 01) before dosing to Day 30, Day 60, Day 90 post-dose, between treatments, within treatment and compare with placebo arm
To assess the effectiveness of test treatment in terms of change in hair fall by using 60-s hair comb test
Change in PGA score for sign of Surface Raggedness
时间窗: From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface raggedness by using 3 point scoring scale Where 0= None, 3= Severe
Change in hair growth rate (Unit= µm)
时间窗: From screening (Within 4 Day) to Day 01, Day 27, Day 30, Day 57, Day 60, Day 87 and Day 90 post-dose, between treatment, within treatment, and compare with placebo arm
To assess the effectiveness of test treatment in terms of change in hair growth rate by using CASALite Nova thorough Phototrichogram
Change in PGA score for sign of brittle nails
时间窗: Baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
To assess the effectiveness of test treatment in terms of change in PGA score for sign of brittle nails by using 5-point scoring scale Where 0= None and 5= Severe
Change in Hair Density (Unit= sqcm)
时间窗: rom baseline (Day 01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo arm
o assess the effectiveness of test treatment in terms of change in hair density by using CASALite Nova thorough phototrichogram
Change in PGA score for sign of Nail Surface Roughness
时间窗: From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface roughness by using 3 point scoring scale Where 0= None, 3= Severe
次要结局
- Change in skin elasticity(From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm)
- Change in facial photographs(Left/Center/Right)(From baseline before usage of test treatments on Day 01, and after usage of test treatments on Day 30, Day 60, Day 90)
- Change in skin hydration(from baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm)
- Change in PGA Score(From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm)
- Change in Complete Blood Count(From Day 01 and Day 90)
- Change in Total Serum Cholesterol(From Day 01 and Day 90)
- Change in HDL level(From Day 01 and Day 90)
- Change in Random Glucose Level(From Day 01 and Day 90)
- Change in fine lines of crow's feet area,(from baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm)
- Change in barrier function of skin(From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm)
- Treatment perception questionnaire(From before dosing of test treatments to after usage of test treatments on Day 30, Day 60, Day 90)
- Change in facial wrinkle(From baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm)
- Change in hair Strength(From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm)
- Change in general appearance of hair(From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm)
- Change in Anagen: Telogen ratio(From baseline (Day01) to Day 90 (+2Days), between treatments, within treatment and compare with placebo treated arm)
- Change in silicon deposits on hair cuticle(From baseline (Day01) before dosing to Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm)
- Change in Skin Texture(From baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm)
- Change in Triglycerides(From Day 01 and Day 90)
- Change in LDL level(From Day 01 and Day 90)
研究者
Dr Nayan Patel
Principal Investigator- Medical Director
NovoBliss Research Pvt Ltd