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

Olistic Research Labs S.L.60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Early Female Pattern Hair Loss (FPHL)

Interventions

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.

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Increase in hair density

From phototrichogram on the Sagittal midline area of the scalp.

Time frame: From enrollment to the end of treatment at 180 days.

Secondary Outcomes

Change in hair shedding

Hair shedding will be assessed by collecting shed hairs during a standardized washing and combing procedure.