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ACTIVE NOT RECRUITING

NCT07300813

Olistic_2025 for Hair Loss, Hair Growth, and Skin Improvement

Sponsor: Bionos Biotech S.L.

View on ClinicalTrials.gov

Summary

The goal of this randomized, double-blind, placebo-controlled clinical trial is to find out whether daily oral intake of the nutraceutical Olistic Next Women can reduce hair loss, improve hair growth and quality, and improve signs of skin aging in women with early female-pattern hair loss. One hundred healthy women aged 50-65 years with initial FPHL will be randomly assigned 1:1 to receive either Olistic Next Women or a matching placebo for 6 months. Participants will drink one vial per day for 28 days, rest 2 days each month, and repeat this cycle for the duration of the study. The main questions are whether Olistic Next Women, compared with placebo, (1) increases hair density and thickness, improves hair growth (anagen/telogen and terminal/vellus ratios), and reduces hair shedding; and (2) improves facial skin parameters related to aging, such as wrinkles, hydration, brightness, elasticity, and firmness. At baseline and at approximately 1, 3, and 6 months, participants will attend clinic visits where hair metrics at two scalp sites will be quantified using HairMetrix imaging; hair shedding will be assessed with standardized comb and wash tests; and hair fiber damage (in a subset) will be evaluated by scanning electron microscopy. Facial skin will be evaluated using 3D wrinkle imaging, Glossymeter, Corneometer, and Cutometer measurements. Participants will also complete the Skindex-29 and a self-perception questionnaire at several time points while maintaining their usual diet and cosmetic routines and avoiding other hair-active treatments or supplements.

Official title: 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'

Key Details

Gender

FEMALE

Age Range

50 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-10-20

Completion Date

2026-06-01

Last Updated

2025-12-24

Healthy Volunteers

Yes

Conditions

Hair Care Hair Loss Female Pattern Hair Loss

Interventions

OTHER

Olistic Next Women

Participants will be provided with Olistic Next Women and instructed to drink one vial orally once daily for 6 months (28 consecutive days followed by 2 days of rest each month). Efficacy will be evaluated at baseline and at approximately 1, 3, and 6 months using HairMetrix® imaging (hair density and growth parameters), standardized hair shedding tests, 3D facial wrinkle imaging, Glossymeter® (shine/brightness), Corneometer® (hydration), Cutometer® (firmness, elasticity, fatigue), and patient-reported questionnaires (Skindex-29 and a self-perception questionnaire). Product is supplied in individual single-dose vials and stored according to the manufacturer's instructions. All procedures occur at Bionos Biotech S.L. facilities.

OTHER

Placebo

Participants will be provided with a matching placebo and instructed to drink one vial orally once daily for 6 months (28 consecutive days followed by 2 days of rest each month). Efficacy will be evaluated at baseline and at approximately 1, 3, and 6 months using HairMetrix® imaging (hair density and growth parameters), standardized hair shedding tests, 3D facial wrinkle imaging, Glossymeter® (shine/brightness), Corneometer® (hydration), Cutometer® (firmness, elasticity, fatigue), and patient-reported questionnaires (Skindex-29 and a self-perception questionnaire). Product is supplied in individual single-dose vials and stored according to the manufacturer's instructions. All procedures occur at Bionos Biotech S.L. facilities.

Inclusion Criteria: * Volunteers with initial FPHL. * 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 exclusion criteria to be added by the customer. * Women who have gone dermatological treatment, that they have introduced minoxidil (oral or topical) at least 6 months prior, and antiandrogens (e.g. finasteride) at least 12 months before the start of the study.

Locations (1)

Bionos Biotech S.L., LabAnalysis Life Science

Valencia, Spain