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

Clinical Evaluation of Hair Loss and Hair Growth Human Volunteers Following a Double-blind, Placebo-controlled, 2:1 Randomized Trial 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 experiencing beginning of female pattern hair loss (FPHL).This 6-month, double-blind, placebo-controlled, 2:1 randomized clinical trial investigates whether daily supplementation with Olistic Next Women leads to significant improvements in hair parameters compared to placebo. The study also monitors the tolerability and safety of the product throughout the intervention.

Study Overview

• Status: Recruiting
• Conditions: Early Female Pattern Hair Loss (FPHL)
• Intervention / Treatment: Other: Placebo control; Dietary supplement: Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, amino acids, and other bioactive compounds, formulated to support hair growth and scalp health in women.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Barmen
    • Wuppertal, Barmen, Germany, 42287
      • Recruiting
      • CentroDerm
      • Contact: Markus Kuchner, MD; Phone Number: +49 (0) 202 - 62 93 370; Email: info@centroderm.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female subjects with female pattern hair loss
• 45-65 years
• Signed informed consent
• The study participant is in good general condition for her age and does not currently have any active diseases that, in the opinion of the investigator, justify exclusion from the study.

Exclusion Criteria:

• Known or documented intolerance/allergy to any of the ingredients of the study product
• Chronic wounds, erosions, pre-existing infected skin or inflammation in the study area
• Suspected non-compliance
• Late onset acne
• Hirsutism
• Any systemic immunosuppressant given within the 12 months prior to the study (e.g. systemic Prednisolone in high doses, Azathioprine, Metothrexate etc.)
• Locally (in the study area) applied products/medicaments which in the opinion of the investigator could lead to an influence of the study results (e.g. topical minoxidil, caffeine etc.)
• Systemically administered products and medicaments which in the opinion of the investigator could lead to an influence of the study results (e.g. hormone-influencing medicaments, medicaments which frequently lead to hypertrichosis or hair loss etc.)
• Subjects receiving stable hormone replacement therapy (HRT) for <6 months prior to screening will be excluded.
• Subjects who follow an exclusively or mainly vegan diet
• Known or documented Gluten intolerance
• Lactose intolerance
• Hyperthyroidism
• Subjects with hypothyroidism with non-stable thyroid-stimulating hormone (TSH) levels will be excluded.
• Other diseases of the scalp which in the opinion of the investigator could lead to an influence of the study results (e.g. Lichen planus, Psoriasis capitis, scarring alopecia etc.)
• Participation in a clinical trial/study
• Participation in a clinical trial/study within the last 30 days
• Deviations from the norm in the following laboratory values in the blood test of the screening visit: zinc, ferritin, selenium, folic acid, vitamin B12, TSH, and CRP. (Only at Baseline)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Arm	Other: Placebo control; Drinkable formulation consisting of an excipient formulation designed to mimic the organoleptic properties of the active product, reproducing its color and texture while achieving a highly similar taste profile.
Active Comparator: Olistic Next Women	Dietary supplement: Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, amino acids, and other bioactive compounds, formulated to support hair growth and scalp health in women.; 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, plant extracts, amino acids, and other bioactive compounds designed to support hair growth and scalp health in women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in hair density	From phototrichogram on the Sagittal midline 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	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

• Sponsor: Olistic Research Labs S.L.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Pharmaceutical Preparations; Inorganic Chemicals; Plant Preparations; Biological Products; Complex Mixtures; Amino Acids; Minerals; Plant Extracts
• Other Study ID Numbers: CT-ON-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No