Clinical Evaluation of a Nutraceutical Supplement (Olistic Women) for Hair Growth and Hair Loss in Human Volunteers

NCT ID: NCT07111312

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2025-09-23

Brief Summary

Hair loss is a multifactorial and complex condition influenced by factors such as hormonal changes, vitamin and mineral deficiencies, genetic predisposition, oxidative stress, aging, inflammation, and psychological stress. This 6-month randomized, double-blind, placebo-controlled study aimed to evaluate the efficacy and safety of a drinkable nutraceutical formulated with natural, high-quality, patented, and standardized ingredients designed to support hair health through multiple biological pathways. A total of 106 premenopausal women aged 18 to 40 years and diagnosed with telogen effluvium were randomized to receive either the nutraceutical (n = 53) or placebo (n = 53). The primary endpoint was the increase in hair density from baseline versus placebo. The secondary endpoint was the change in the anagen-to-catagen/telogen (A:C/T) ratio. These parameters were assessed using phototrichoscopy and phototrichogram via TrichoScan®. The study was approved by an ethics committee and conducted by two independent board-certified dermatologists at two study sites.

Conditions

Telogen Effluvium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active Product Arm

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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 Arm

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo control

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age: 18-40 years
• Sex: female
• Telogen effluvium diagnosis with hair loss > 100 hairs, confirmed using validated "modified wash test"
• Otherwise, healthy volunteers
• Refraining from systemic, topical, oral products with similar effects to the active product
• Signed informed consent
• Maintenance of daily cosmetic and dietary routine
• Availability to attend all visits
• Compliance with all protocol requirements

Exclusion Criteria

• Previous use of active product
• Participation in similar studies or usage of anti-hair loss products within the last 3 months
• History of dermatological treatment (e.g. mesotherapy) and/or hair transplant
• Skin or scalp diseases (e.g. psoriasis, dermatitis, alopecias)
• Alopecia secondary to medical diseases (e.g. hypothyroidism, anemia)
• Ongoing treatment for or diagnosis of systemic disease
• Hormonal treatment (oral or topical contraceptives) within 6 months prior to study start
• Known allergy or intolerance, including to any of the ingredients of the active product
• Pregnancy, post-partum (6 months) or breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Olistic Research Labs S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zurko-CTC

Barcelona, , Spain

Clínica AB Derma

Madrid, , Spain

Countries

Spain

References

Bernardez C, Podlipnik S, Westgate GE, Paus R, Zamfir L, Grohmann D, Saez Moya M. Efficacy and Safety of a Drinkable Nutraceutical in Premenopausal Women with Telogen Effluvium: A 6-Month, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2025 Nov 25. doi: 10.1007/s13555-025-01585-x. Online ahead of print.

Reference Type: DERIVED

PMID: 41288927 (View on PubMed)

Other Identifiers

CT-OW-02

Identifier Type: -

Identifier Source: org_study_id