Early Female Pattern Hair Loss (FPHL)
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTDrinkable multifactorial food supplement containing vitamins, minerals, plant extracts, amino acids, and other bioactive compounds, formulated to support hair growth and scalp health in women.
Drinkable multifactorial food supplement in liquid form, administered once daily in a 25 mL single-dose vial, for a duration of 180 days. The formulation contains a combination of vitamins, minerals, plant extracts, amino acids, and other bioactive compounds designed to support hair growth and scalp health in women.
OTHERPlacebo control
Drinkable formulation consisting of an excipient formulation designed to mimic the organoleptic properties of the active product, reproducing its color and texture while achieving a highly similar taste profile.
Sponsors
Olistic Research Labs S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase in hair density | From enrollment to the end of treatment at 180 days. | From phototrichogram on the Sagittal midline area of the scalp. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hair shedding | From enrollment to the end of treatment at 180 days. | Hair shedding will be assessed by collecting shed hairs during a standardized washing and combing procedure. |
Countries
Germany
Outcome results
None listed