Olistic_2025 for Hair Loss, Hair Growth, and Skin Improvement

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.

NCT Number	NCT07300813
Lead Sponsor	Bionos Biotech S.L.
Conditions	Hair Care, Hair Loss, Female Pattern Hair Loss
Enrollment	100 participants
Start Date	2025-10-20
Primary Completion	2026-05-04 (estimated)
Study Completion	2026-06-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-24