Clinical Evaluation of Hair Loss and Hair Growth Human Volunteers Following a Double-blind, Placebo-controlled, 2:1 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
- 60
- 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 experiencing beginning of female pattern hair loss (FPHL).This 6-month, double-blind, placebo-controlled, 2:1 randomized clinical trial investigates whether daily supplementation with Olistic Next Women leads to significant improvements in hair parameters compared to placebo. 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects with female pattern hair loss
- •45-65 years
- •Signed informed consent
- •The study participant is in good general condition for her age and does not currently have any active diseases that, in the opinion of the investigator, justify exclusion from the study.
排除标准
- •Known or documented intolerance/allergy to any of the ingredients of the study product
- •Chronic wounds, erosions, pre-existing infected skin or inflammation in the study area
- •Suspected non-compliance
- •Late onset acne
- •Hirsutism
- •Any systemic immunosuppressant given within the 12 months prior to the study (e.g. systemic Prednisolone in high doses, Azathioprine, Metothrexate etc.)
- •Locally (in the study area) applied products/medicaments which in the opinion of the investigator could lead to an influence of the study results (e.g. topical minoxidil, caffeine etc.)
- •Systemically administered products and medicaments which in the opinion of the investigator could lead to an influence of the study results (e.g. hormone-influencing medicaments, medicaments which frequently lead to hypertrichosis or hair loss etc.)
- •Subjects receiving stable hormone replacement therapy (HRT) for <6 months prior to screening will be excluded.
- •Subjects who follow an exclusively or mainly vegan diet
- •Known or documented Gluten intolerance
- •Lactose intolerance
- •Hyperthyroidism
- •Subjects with hypothyroidism with non-stable thyroid-stimulating hormone (TSH) levels will be excluded.
- •Other diseases of the scalp which in the opinion of the investigator could lead to an influence of the study results (e.g. Lichen planus, Psoriasis capitis, scarring alopecia etc.)
- •Participation in a clinical trial/study
- •Participation in a clinical trial/study within the last 30 days
- •Deviations from the norm in the following laboratory values in the blood test of the screening visit: zinc, ferritin, selenium, folic acid, vitamin B12, TSH, and CRP. (Only at Baseline)
研究组 & 干预措施
Placebo Arm
干预措施: Placebo control (Other)
Olistic Next Women
干预措施: Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, amino acids, and other bioactive compounds, formulated to support hair growth and scalp health in women. (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 Sagittal midline area of the scalp.
次要结局
- Change in hair shedding(From enrollment to the end of treatment at 180 days.)