Efficacy and Safety Evaluation of a Nutraceutical Supplement for Hair Growth, Hair Loss and Skin Improvement in Human Volunteers

January 9, 2026 updated by: Olistic Research Labs S.L.

Clinical Evaluation of Hair and Skin Health in Human Volunteers, Following a 6-month Open-label Interventional Study of 'Olistic Next Women'

The purpose of this clinical trial is to evaluate the efficacy and safety of Olistic Next Women, a nutraceutical supplement, in women diagnosed with early FPHL.This 6-month, open-label, interventional clinical trial investigates whether daily supplementation with Olistic Next Women leads to significant improvements in hair parameters. The study also monitors the tolerability and safety of the product throughout the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain
        • Bionos Biotech Clínica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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.
  • 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 investigator.
  • Allergy or reactivity to some of the components of the product, or a product with similar category than tested one.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Product Arm
Dietary supplement: Drinkable multifactorial food supplement containing vitamins, minerals, amino acids, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women +50.
Drinkable multifactorial food supplement in liquid form, administered once daily in a 25 mL single-dose vial, for a duration of 180 days. The formulation contains a combination of vitamins, minerals, amino acids, plant extracts, and other bioactive compounds designed to support hair growth and scalp health in women +50.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in hair density
Time Frame: From enrollment to the end of treatment at 180 days.
From phototrichogram on the mid interparietal area of the scalp.
From enrollment to the end of treatment at 180 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hair shedding
Time Frame: From enrollment to the end of treatment at 180 days.
Hair shedding will be assessed by collecting shed hairs during a standardized washing and combing procedure.
From enrollment to the end of treatment at 180 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olistic Research Labs S.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2024

Primary Completion (Actual)

May 20, 2025

Study Completion (Actual)

December 23, 2025

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Estimated)

December 23, 2025

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-ON-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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