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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorOlistic Research Labs S.L.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Olistic Next WomenActive comparator 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Increase in hair density

From phototrichogram on the Sagittal midline area of the scalp.

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

Secondary outcomes

1

Change in hair shedding

Hair shedding will be assessed by collecting shed hairs during a standardized washing and combing procedure.

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

Other outcomes

Sponsors and contacts

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