Olistic_2025 for Hair Loss, Hair Growth, and Skin Improvement

NCT ID: NCT07300813

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-20
• Study Completion Date: 2026-06-01

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.

Detailed Description

Hair loss in women and skin aging are multifactorial processes influenced by intrinsic factors (genetics, hormonal changes, chronological aging) and extrinsic factors (UV exposure, environmental stressors, lifestyle). Female pattern hair loss (FPHL) is characterized by gradual thinning and a reduction in hair density, often associated with a decrease in the terminal/vellus hair ratio and changes in the anagen/telogen balance. In parallel, skin aging manifests as wrinkles, loss of elasticity and firmness, reduced hydration, and altered barrier function. Nutraceuticals containing bioactive compounds such as collagen-derived amino acids, plant extracts, vitamins, and minerals have been proposed as a supportive strategy to improve hair and skin parameters from within.

In this double-blind, placebo-controlled, 1:1 randomized cosmetic study, investigators will assess the efficacy of the oral supplement "Olistic Next Women" on hair loss/growth and age-related skin parameters in healthy adult women with initial FPHL. One hundred volunteers aged 50-65 years with early FPHL, confirmed through dermatological assessment, will be enrolled at Bionos Biotech S.L. (Valencia, Spain) after providing written informed consent and meeting predefined inclusion and exclusion criteria. Participants will be randomized to receive either Olistic Next Women or a matching placebo and will consume one vial daily for 28 consecutive days followed by 2 days of rest each month, for a total treatment duration of 6 months. The product and placebo are manufactured in compliance with relevant EU regulations regarding safety, microbiology, allergens, and heavy metals.

Hair and skin assessments will be performed at baseline and during follow-up visits to enable comparisons over time between active and placebo groups. A dermatologist will conduct an initial hair evaluation, followed by standardized measurements at multiple time points. At baseline (D0), month 3 (D90), and month 6 (D180), hair density and growth parameters will be quantified at two scalp sites (behind the ear and at the top of the head, where FPHL is more evident) using HairMetrix® imaging. Parameters will include terminal/vellus ratio, average hairs per follicular unit, hair width, follicle count per cm², hair count per cm², anagen/telogen ratio, and short-term growth rate. Hair shedding will be evaluated at several visits using standardized comb and wash tests after controlled intervals without washing or combing. In a subset of 10 volunteers, hair fiber damage and integrity will be assessed by scanning electron microscopy. Hair volume, general appearance, and overall hair quality will be graded by clinical scoring, and hair shine will be measured using a Glossymeter® probe.

Facial skin will be evaluated at baseline and follow-up visits using non-invasive instrumental methods. Wrinkle area, depth, and volume will be quantified by 3D imaging; skin brightness will be measured with a Glossymeter®; hydration will be assessed using a Corneometer®; and elasticity and firmness will be measured with a Cutometer®. Participants will also complete the Skindex-29 questionnaire to capture the impact of hair and skin status on quality of life, as well as a self-perception questionnaire to document subjective impressions of hair and skin changes over the course of treatment.

Throughout the study, participants will be instructed to maintain their usual diet and basic hygiene habits, to avoid initiating new oral supplements or systemic/topical products with similar effects to the investigational product, and to refrain from intense or invasive cosmetic treatments. Major changes in hairstyle or routine that could interfere with measurements will not be permitted. Compliance with product intake and study instructions will be supported through written guidelines and regular contact with the research team. The primary analysis will compare changes from baseline to post-treatment time points between the Olistic Next Women and placebo groups using appropriate statistical methods for continuous outcomes, with two-sided tests and a significance level of 0.05. The planned sample size of 100 women is based on prior experience and is expected to provide adequate power to detect clinically relevant differences in key hair and skin parameters.

The study will be conducted in accordance with the Declaration of Helsinki, applicable regulations, and local ethics committee approval. All participants will provide written informed consent prior to any study procedures. Data will be coded and handled under Spanish data protection law, and study records will be retained according to regulatory requirements.

Conditions

Hair Care; Hair Loss; Female Pattern Hair Loss

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Olistic Next Women

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

Group Type: EXPERIMENTAL

Olistic Next Women

Intervention Type: 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.

Placebo

This group will be provided with placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.
• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bionos Biotech S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adela Serrano Gimeno, PhD

Role: PRINCIPAL_INVESTIGATOR

Bionos Biotech S.L. , LabAnalysis Life Science

Locations

Bionos Biotech S.L., LabAnalysis Life Science

Valencia, , Spain

Countries

Spain

Other Identifiers

Olistic_2025

Identifier Type: -

Identifier Source: org_study_id