Clinical Evaluation of Hair Loss, Hair Growth, and Skin Improvement in Human Volunteers Following a Double-blind, Placebo-controlled, 1:1 Randomized Trial of 'Olistic Next Women'
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change from baseline in hair density (hair count per cm²) measured by HairMetrix®.
研究概览
简要总结
The goal of this randomized, double-blind, placebo-controlled clinical trial is to find out whether daily oral intake of the nutraceutical Olistic Next Women can reduce hair loss, improve hair growth and quality, and improve signs of skin aging in women with early female-pattern hair loss. One hundred healthy women aged 50-65 years with initial FPHL will be randomly assigned 1:1 to receive either Olistic Next Women or a matching placebo for 6 months. Participants will drink one vial per day for 28 days, rest 2 days each month, and repeat this cycle for the duration of the study.
The main questions are whether Olistic Next Women, compared with placebo, (1) increases hair density and thickness, improves hair growth (anagen/telogen and terminal/vellus ratios), and reduces hair shedding; and (2) improves facial skin parameters related to aging, such as wrinkles, hydration, brightness, elasticity, and firmness. At baseline and at approximately 1, 3, and 6 months, participants will attend clinic visits where hair metrics at two scalp sites will be quantified using HairMetrix imaging; hair shedding will be assessed with standardized comb and wash tests; and hair fiber damage (in a subset) will be evaluated by scanning electron microscopy. Facial skin will be evaluated using 3D wrinkle imaging, Glossymeter, Corneometer, and Cutometer measurements. Participants will also complete the Skindex-29 and a self-perception questionnaire at several time points while maintaining their usual diet and cosmetic routines and avoiding other hair-active treatments or supplements.
详细描述
Hair loss in women and skin aging are multifactorial processes influenced by intrinsic factors (genetics, hormonal changes, chronological aging) and extrinsic factors (UV exposure, environmental stressors, lifestyle). Female pattern hair loss (FPHL) is characterized by gradual thinning and a reduction in hair density, often associated with a decrease in the terminal/vellus hair ratio and changes in the anagen/telogen balance. In parallel, skin aging manifests as wrinkles, loss of elasticity and firmness, reduced hydration, and altered barrier function. Nutraceuticals containing bioactive compounds such as collagen-derived amino acids, plant extracts, vitamins, and minerals have been proposed as a supportive strategy to improve hair and skin parameters from within.
In this double-blind, placebo-controlled, 1:1 randomized cosmetic study, investigators will assess the efficacy of the oral supplement "Olistic Next Women" on hair loss/growth and age-related skin parameters in healthy adult women with initial FPHL. One hundred volunteers aged 50-65 years with early FPHL, confirmed through dermatological assessment, will be enrolled at Bionos Biotech S.L. (Valencia, Spain) after providing written informed consent and meeting predefined inclusion and exclusion criteria. Participants will be randomized to receive either Olistic Next Women or a matching placebo and will consume one vial daily for 28 consecutive days followed by 2 days of rest each month, for a total treatment duration of 6 months. The product and placebo are manufactured in compliance with relevant EU regulations regarding safety, microbiology, allergens, and heavy metals.
Hair and skin assessments will be performed at baseline and during follow-up visits to enable comparisons over time between active and placebo groups. A dermatologist will conduct an initial hair evaluation, followed by standardized measurements at multiple time points. At baseline (D0), month 3 (D90), and month 6 (D180), hair density and growth parameters will be quantified at two scalp sites (behind the ear and at the top of the head, where FPHL is more evident) using HairMetrix® imaging. Parameters will include terminal/vellus ratio, average hairs per follicular unit, hair width, follicle count per cm², hair count per cm², anagen/telogen ratio, and short-term growth rate. Hair shedding will be evaluated at several visits using standardized comb and wash tests after controlled intervals without washing or combing. In a subset of 10 volunteers, hair fiber damage and integrity will be assessed by scanning electron microscopy. Hair volume, general appearance, and overall hair quality will be graded by clinical scoring, and hair shine will be measured using a Glossymeter® probe.
Facial skin will be evaluated at baseline and follow-up visits using non-invasive instrumental methods. Wrinkle area, depth, and volume will be quantified by 3D imaging; skin brightness will be measured with a Glossymeter®; hydration will be assessed using a Corneometer®; and elasticity and firmness will be measured with a Cutometer®. Participants will also complete the Skindex-29 questionnaire to capture the impact of hair and skin status on quality of life, as well as a self-perception questionnaire to document subjective impressions of hair and skin changes over the course of treatment.
Throughout the study, participants will be instructed to maintain their usual diet and basic hygiene habits, to avoid initiating new oral supplements or systemic/topical products with similar effects to the investigational product, and to refrain from intense or invasive cosmetic treatments. Major changes in hairstyle or routine that could interfere with measurements will not be permitted. Compliance with product intake and study instructions will be supported through written guidelines and regular contact with the research team. The primary analysis will compare changes from baseline to post-treatment time points between the Olistic Next Women and placebo groups using appropriate statistical methods for continuous outcomes, with two-sided tests and a significance level of 0.05. The planned sample size of 100 women is based on prior experience and is expected to provide adequate power to detect clinically relevant differences in key hair and skin parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study is double-blind with matching placebo. Participants, care providers, investigators, and outcomes assessors are unaware of treatment allocation. Active product and placebo are identical in appearance, packaging, labeling, and administration schedule. Randomization codes are held by an independent party and will not be broken until database lock, except in case of medical emergency.
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Volunteers with initial FPHL.
- •Commitment not to use systemic, topical, or oral products with an effect similar to that of the product to be evaluated throughout the study period.
- •Do not change the daily routine regarding the use of cosmetic products and eating habits.
- •Commitment to comply with all protocol requirements specified in the subject information sheet.
- •Availability to comply with all study visits.
排除标准
- •Allergy or reactivity to some of the components of the product, or a product with similar category than tested one.
- •Women who have undergone dermatological treatment for hair loss (PRPs, mesotherapy, etc.) or hair transplant.
- •Scalp diseases: cicatricial alopecia, alopecia areata, folliculitis decalvans, psoriasis, moderate severe seborrheic dermatitis, eczema, cancer, etc.
- •Women who present alopecia because of a medical illness (hypothyroidism, anemia, lupus, etc.).
- •Relevant cutaneous marks in the experimental areas, which could interfere with the measurements (scars, sunburns, etc.).
- •In-use relevant pharmacological or hormonal treatment (eg. valproic acid, carbamazepine, phenytoin).
- •Women with thyroid alteration (hyper- or hypothyroidism)
- •Women who have previously participated in similar studies or who have used anti-hair loss products in the last 3 months.
- •Women who are being treated with anticoagulants, antifungals, anxiolytics, amphetamines, retinoids, iron, antithyroid, anticonvulsants, beta blockers and/or ACE inhibitors, minoxidil, finasteride, etc.
- •Women who started hormonal treatment (oral or topical contraceptives) in the 6 months prior to the start of the study.
- •Women who started taking any drug chronically less than 6 months before the start of the study (they should have a stable situation with the medication over 6 months).
- •Modification of the usual diet: low-calorie diet, Atkins diet, etc.
- •Pregnant, postpartum (6 months) or breastfeeding women, or who intend to get pregnant during the duration of the study.
- •Evidence of systemic diseases (e.g. cardiac disease, psychiatric disease, etc.) or gastrointestinal diseases.
- •Serious conditions or illnesses that, in the opinion of the researcher, may be aggravated by participation in the study or that put the development of the study at risk.
- •Planned hairstyle changes throughout the study
- •Presence of skin diseases or melanomas
- •Forecast of change of routine or relevant way of life, during the period of study.
- •Other exclusion criteria to be added by the customer.
- •Women who have gone dermatological treatment, that they have introduced minoxidil (oral or topical) at least 6 months prior, and antiandrogens (e.g. finasteride) at least 12 months before the start of the study.
结局指标
主要结局
Change from baseline in hair density (hair count per cm²) measured by HairMetrix®.
时间窗: Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).
Change in hair density, expressed as hair count per cm², from baseline to follow-up visits. Hair density is assessed using standardized HairMetrix® imaging at predefined scalp sites. To ensure measurement accuracy and reproducibility, all assessments are performed 2 days after standardized scalp clipping, allowing sufficient hair regrowth for reliable detection and analysis.
次要结局
- Change from baseline in terminal/vellus hair ratio (unitless) measured by HairMetrix®(Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).)
- Change from baseline in mean hair shaft width (µm) measured by HairMetrix®(Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).)
- Change from baseline in follicle count per cm² measured by HairMetrix®(Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).)
- Change from baseline in anagen/telogen ratio (unitless) measured by HairMetrix®(Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).)
- Change from baseline in wrinkle volume (mm³) measured by 3D imaging.(Baseline and ~1, 3, 6 months.)
- Change from baseline in short-term hair growth rate (mm/day) measured by HairMetrix®(Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).)
- Change from baseline in depth volume (mm³) measured by 3D imaging(Baseline and ~1, 3, 6 months.)
- Change from baseline in wrinkle area (mm³) measured by 3D imaging(Baseline and ~1, 3, 6 months.)
- Change from baseline in skin firmness (Cutometer® R0, mm)(Baseline and ~1, 3, 6 months.)
- Change from baseline in skin hydration (Corneometer units, a.u.)(Baseline and ~1, 3, 6 months.)
- Change from baseline in number of fallen hairs after combing assessed by comb test(Baseline and ~1, 3, 6 months.)
- Change from baseline in skin gloss/brightness (Gloss units)(Baseline and ~1, 3, 6 months.)
- Change from baseline in skin elasticity (Cutometer® R2, unitless)(Baseline and ~1, 3, 6 months.)
- Change from baseline in Skindex-29 overall score (0-100; higher = worse quality of life)(before treatment, after 1-, 3 and 6 months treatment.)
- Change from baseline in Self-Perception Questionnaire total score(before treatment, after 1-, 3 and 6 months treatment.)
- Change from baseline in hair volume, general appearance, and hair quality assessed by clinical scoring(Baseline and ~1, 3, 6 months.)
- Change from baseline in hair fiber integrity and thickness assessed by scanning electron microscopy(Baseline and ~1, 3, 6 months.)
- Change from baseline in number of fallen hairs after washing assessed by wash test(Baseline and ~1, 3, 6 months.)