NCT07300228已完成不适用
Clinical Evaluation of Hair and Skin Health in Human Volunteers, Following a 6-month Open-label Interventional Study of 'Olistic Next Women'
Olistic Research Labs S.L.1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2024年9月16日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Increase in hair density
研究概览
简要总结
The purpose of this clinical trial is to evaluate the efficacy and safety of Olistic Next Women, a nutraceutical supplement, in women diagnosed with early FPHL.This 6-month, open-label, interventional clinical trial investigates whether daily supplementation with Olistic Next Women leads to significant improvements in hair parameters. The study also monitors the tolerability and safety of the product throughout the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Women aged 50-
- •Volunteers with initial FPHL. (Images will be sent to a dermatologist for assessment).
- •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
- •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.
- •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 investigator.
- •Allergy or reactivity to some of the components of the product, or a product with similar category than tested one.
- •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
研究组 & 干预措施
Active Product Arm
Experimental
干预措施: Drinkable multifactorial food supplement containing vitamins, minerals, amino acids, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women +50. (Dietary Supplement)
结局指标
主要结局
Increase in hair density
时间窗: From enrollment to the end of treatment at 180 days.
From phototrichogram on the mid interparietal area of the scalp.
次要结局
- Change in hair shedding(From enrollment to the end of treatment at 180 days.)
研究者
研究点 (1)
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