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Clinical Evaluation of a Nutraceutical Supplement for Hair Growth, Hair Loss and Skin Improvement in Human Volunteers Versus Placebo | Clinical Trials | Clareo Health

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

Clinical Evaluation of Hair Loss, Hair Growth, and Skin Improvement in Human Volunteers Following a Double-blind, Placebo-controlled, 1:1 Randomized Trial of 'Olistic Next Women'

NCT07111299•Olistic Research Labs S.L.

View on ClinicalTrials.gov

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 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.

Eligibility

Age

50 - 65 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Women aged 50-65.
•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.
+9 more criteria

Locations (1)

Bionos Biotech Clínica

Valencia, Spain

Key Dates

Start Date

October 13, 2025

Primary Completion Date

July 1, 2026

Completion Date

September 1, 2026

Last Updated

December 30, 2025

Enrollment

100

ESTIMATED participants

Conditions

Early Female Pattern Hair Loss (FPHL)

Interventions

Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.

DIETARY_SUPPLEMENT

Placebo Control

OTHER