Olistic Next Women supplement for early female hair thinning and skin support
Clinical Evaluation of Hair Loss and Hair Growth Human Volunteers Following a Double-blind, Placebo-controlled, 2:1 Randomized Trial of 'Olistic Next Women'
This trial will test whether daily Olistic Next Women drinkable supplement helps women aged 45–65 with early female pattern hair loss grow thicker hair and improve scalp and skin over six months compared with a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | Female |
| Sponsor | Olistic Research Labs S.L. Industry-sponsored |
| Locations | 1 site (Wuppertal, Barmen) |
| Trial ID | NCT07347145 on ClinicalTrials.gov |
What this trial studies
This is a 6-month, double-blind, placebo-controlled, randomized (2:1) interventional trial. Women with early female pattern hair loss will take a daily drinkable nutraceutical containing vitamins, minerals, plant extracts, amino acids, and other bioactive compounds or a placebo. Investigators will measure hair parameters such as hair density and thickness and monitor scalp and skin condition at baseline and scheduled follow-ups. Safety and tolerability will be recorded throughout the intervention period.
Who should consider this trial
Good fit: Women aged 45–65 with early female pattern hair loss who are in generally good health, willing to provide informed consent, and not using conflicting topical or systemic hair treatments are ideal candidates.
Not a fit: Patients with advanced or scarring hair loss, known allergy to product ingredients, active infected or inflamed scalp conditions, recent systemic immunosuppression, or current use of topical agents that affect hair growth are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the supplement could provide a well-tolerated, non-prescription option to slow or partially reverse early hair thinning and improve scalp skin quality.
How similar studies have performed: Some prior small studies of multinutrient and plant-based supplements have reported modest improvements in hair quality, but the overall evidence is mixed and larger controlled trials are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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)
Where this trial is running
Wuppertal, Barmen
- CentroDerm — Wuppertal, Barmen, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.