Olistic_2025 for Hair Loss, Hair Growth, and Skin Improvement

NCT07300813 | Active Not Recruiting

• 1 other identifier: Olistic_2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hair Loss; Female Pattern Hair Loss; Hair Care

Keywords

Hair density; Female pattern hair loss; Hair growth; Skin aging; Facial wrinkles; Oral nutraceutical; Skin firmness; Skin elasticity; Dietary supplement; Collagen peptides

Outcome Measures

Primary Outcomes (1)

• Change from baseline in hair density (hair count per cm²) measured by HairMetrix®.

  Change in hair density, expressed as hair count per cm², from baseline to follow-up visits. Hair density is assessed using standardized HairMetrix® imaging at predefined scalp sites. To ensure measurement accuracy and reproducibility, all assessments are performed 2 days after standardized scalp clipping, allowing sufficient hair regrowth for reliable detection and analysis.

  Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).

Secondary Outcomes (18)

• Change from baseline in terminal/vellus hair ratio (unitless) measured by HairMetrix®

  Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).

• Change from baseline in mean hair shaft width (µm) measured by HairMetrix®

  Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).

• Change from baseline in follicle count per cm² measured by HairMetrix®

  Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).

• Change from baseline in anagen/telogen ratio (unitless) measured by HairMetrix®

  Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).

• Change from baseline in short-term hair growth rate (mm/day) measured by HairMetrix®

  Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).

Study Arms (2)

Olistic Next Women

EXPERIMENTAL

This group will be provided with the product Olistic Next Women.

Other: Olistic Next Women

Placebo

PLACEBO COMPARATOR

This group will be provided with placebo.

Other: Placebo

Interventions

Placebo OTHER

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.

Placebo

Olistic Next Women OTHER

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.

Olistic Next Women

Eligibility Criteria

• Age: 50 Years - 65 Years
• Gender Eligibility Details: Only participants who self-identify as women are eligible for this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bionos Biotech S.L.: lead

Study Sites (1)

Bionos Biotech S.L., LabAnalysis Life Science

Valencia, 46007, Spain

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Adela Serrano Gimeno, PhD

  Bionos Biotech S.L. , LabAnalysis Life Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is double-blind with matching placebo. Participants, care providers, investigators, and outcomes assessors are unaware of treatment allocation. Active product and placebo are identical in appearance, packaging, labeling, and administration schedule. Randomization codes are held by an independent party and will not be broken until database lock, except in case of medical emergency.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned in a 1:1 ratio to receive either Olistic Next Women or a matching placebo and remain in the same group for the full 6-month treatment period (parallel two-arm design, no crossover).

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 24, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): May 4, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)