Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07347145

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Early Female Pattern Hair Loss (FPHL)

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CentroDerm

Wuppertal, Barmen, 42287, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Increase in hair density

    Time frame: From enrollment to the end of treatment at 180 days.

    From phototrichogram on the Sagittal midline area of the scalp.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Olistic Research Labs S.L.

Industry

Registry information

Official study title

Clinical Evaluation of Hair Loss and Hair Growth Human Volunteers Following a Double-blind, Placebo-controlled, 2:1 Randomized Trial of 'Olistic Next Women'

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.