Clinical Evaluation of a Nutraceutical Supplement for Hair Growth, Hair Loss and Skin Improvement in Human Volunteers

Olistic Research Labs S.L.

Status

Enrolling

Conditions

Early Female Pattern Hair Loss (FPHL)

Treatments

Other: Placebo control

Dietary Supplement: 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.

Study type

Interventional

Funder types

Industry

Identifiers

NCT07347145

CT-ON-02

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

Female

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

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)