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

NCT07111299 | Active Not Recruiting

• 1 other identifier: CT-ON-03
• Study Type: interventional
• Target: 100
• 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 FPHL. This 6-month, double-blind, placebo-controlled, 1:1 randomized clinical trial investigates whether daily supplementation with Olistic Women or 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 (4)

Active Product Arm - Olistic Next Women

EXPERIMENTAL

Dietary Supplement: Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women over 35 years.

Placebo Arm - Olistic Next Women

PLACEBO COMPARATOR

Other: Placebo Control

Active Product Arm - Olistic Women

EXPERIMENTAL

Dietary Supplement: Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women 18-35 years.

Placebo Arm - Olistic Women

PLACEBO COMPARATOR

Other: Placebo Control

Interventions

Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women 18-35 years. 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. Target population: women aged 18-35. Not recommended during pregnancy or breastfeeding.

Active Product Arm - Olistic 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 - Olistic Next Women; Placebo Arm - Olistic Women

Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women over 35 years. 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. Target population: women aged \>35. Not recommended during pregnancy or breastfeeding.

Active Product Arm - Olistic Next Women

Eligibility Criteria

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

You may qualify if:

• Women aged 18-65.
• 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.
• Commitment to comply with all protocol requirements specified in the subject information sheet.
• Availability to comply with all study visits.

You may not qualify if:

• 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.).
• Relevant cutaneous marks in the experimental areas, which could interfere with the measurements (scars, sunburns, etc.).
• In-use relevant pharmacological or hormonal treatment (eg. valproic acid, carbamazepine, phenytoin).
• Women with thyroid alteration (hyper- or hypothyroidism)
• Women who have previously participated in similar studies or who have used anti-hair loss products in the last 3 months.
• Women who are being treated with anticoagulants, antifungals, anxiolytics, amphetamines, retinoids, iron, antithyroid, anticonvulsants, beta blockers and/or ACE inhibitors, minoxidil, finasteride, etc.
• Women who started hormonal treatment (oral or topical contraceptives) in the 6 months prior to the start of the study.
• Women who started taking any drug chronically less than 6 months before the start of the study (they should have a stable situation with the medication over 6 months).
• Modification of the usual diet: low-calorie diet, Atkins diet, etc.
• Pregnant, postpartum (6 months) or breastfeeding women, or who intend to get pregnant during the duration of the study.
• Evidence of systemic diseases (e.g. cardiac disease, psychiatric disease, etc.) or gastrointestinal diseases.
• Serious conditions or illnesses that, in the opinion of the researcher, may be aggravated by participation in the study or that put the development of the study at risk.

Sponsors & Collaborators

• Olistic Research Labs S.L.: lead

Study Sites (1)

Bionos Biotech Clínica

Valencia, Spain

Location

MeSH Terms

Interventions

Minerals; Plant Extracts

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

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: July 31, 2025
• First Posted: August 8, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 23, 2026

Record last verified: 2025-12

Locations

ES (1)