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

NCT07347145 | Recruiting

• 1 other identifier: CT-ON-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Female Pattern Hair Loss (FPHL)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in hair shedding

  From enrollment to the end of treatment at 180 days.

Study Arms (2)

Olistic Next Women

ACTIVE COMPARATOR

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.

Placebo Arm

PLACEBO COMPARATOR

Other: Placebo control

Interventions

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. DIETARY_SUPPLEMENT

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.

Olistic Next Women

Placebo control OTHER

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.

Placebo Arm

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects with female pattern hair loss
• years
• Signed informed consent

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Olistic Research Labs S.L.: lead

Study Sites (1)

CentroDerm

Wuppertal, Barmen, 42287, Germany

RECRUITING

MeSH Terms

Interventions

Minerals; Plant Extracts; Amino Acids

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 16, 2026
• Study Start: March 3, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)