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 FPHL. This 6-month, double-blind, placebo-controlled, 1:1 randomized clinical trial investigates whether daily supplementation with Olistic Women or 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, and other bioactive compounds, formulated to support hair growth and scalp health in women 18-35 years.
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. Target population: women aged 18-35. Not recommended during pregnancy or breastfeeding.
DIETARY_SUPPLEMENTDrinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women over 35 years.
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. Target population: women aged \>35. Not recommended during pregnancy or breastfeeding.
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
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18-65. * Volunteers with initial FPHL. (Images will be sent to a dermatologist for assessment). * Commitment not to use systemic, topical, or oral products with an effect similar to that of the product to be evaluated throughout the study period. * Do not change the daily routine regarding the use of cosmetic products and eating habits. * Commitment to comply with all protocol requirements specified in the subject information sheet. * Availability to comply with all study visits.
Exclusion criteria
* Allergy or reactivity to some of the components of the product, or a product with similar category than tested one. * Women who have undergone dermatological treatment for hair loss (PRPs, mesotherapy, etc.) or hair transplant. * Scalp diseases: cicatricial alopecia, alopecia areata, folliculitis decalvans, psoriasis, moderate severe seborrheic dermatitis, eczema, cancer, etc. * Women who present alopecia because of a medical illness (hypothyroidism, anemia, lupus, etc.). * Relevant cutaneous marks in the experimental areas, which could interfere with the measurements (scars, sunburns, etc.). * In-use relevant pharmacological or hormonal treatment (eg. valproic acid, carbamazepine, phenytoin). * Women with thyroid alteration (hyper- or hypothyroidism) * Women who have previously participated in similar studies or who have used anti-hair loss products in the last 3 months. * Women who are being treated with anticoagulants, antifungals, anxiolytics, amphetamines, retinoids, iron, antithyroid, anticonvulsants, beta blockers and/or ACE inhibitors, minoxidil, finasteride, etc. * Women who started hormonal treatment (oral or topical contraceptives) in the 6 months prior to the start of the study. * Women who started taking any drug chronically less than 6 months before the start of the study (they should have a stable situation with the medication over 6 months). * Modification of the usual diet: low-calorie diet, Atkins diet, etc. * Pregnant, postpartum (6 months) or breastfeeding women, or who intend to get pregnant during the duration of the study. * Evidence of systemic diseases (e.g. cardiac disease, psychiatric disease, etc.) or gastrointestinal diseases. * Serious conditions or illnesses that, in the opinion of the researcher, may be aggravated by participation in the study or that put the development of the study at risk. * Planned hairstyle changes throughout the study * Presence of skin diseases or melanomas. * Forecast of change of routine or relevant way of life, during the period of study. * Other
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
Spain
Outcome results
None listed