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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-65
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 FPHL.

This 6-month, double-blind, placebo-controlled, 1:1 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

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.

Disqualifiers

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

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.).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, 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

100 Participants
are divided into 2 treatment groups
Group A: Active Product ArmActive 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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