Oral Minoxidil With or Without a Multifactorial Drinkable Nutraceutical in Female Pattern Hair Loss: a Retrospective Study

NCT07862374 | Not Yet Recruiting

• 1 other identifier: CT-OW-03
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective observational study evaluates the outcomes of a multifactorial drinkable nutraceutical combined with oral minoxidil, compared with oral minoxidil monotherapy, in women with female pattern hair loss (FPHL) treated in routine clinical practice. Data were collected from a cohort of women with FPHL (Ludwig or Olsen grade I) who received either oral minoxidil alone or oral minoxidil plus the nutraceutical for 6 months. Outcomes were assessed at baseline and at 6 months. The main assessment was standardized phototrichoscopy in the frontal region. Patient-reported outcomes included a hair-specific adaptation of the Skindex-29 quality-of-life questionnaire and a treatment perception questionnaire. Adverse events were also recorded. The study aims to explore whether adding the nutraceutical to oral minoxidil gives additional benefits in hair density, hair thickness and quality of life compared with oral minoxidil alone.

Conditions

Female Pattern Hair Loss; Female Pattern Hair Loss, Androgenic Alopecia

Outcome Measures

Primary Outcomes (1)

• Triple and Bigger Follicular Units

  Change in triple and bigger follicular units analyzed via phototrichoscopy.

  6 months

Secondary Outcomes (3)

• Single and Double Follicular Units

  6 months

• Average Hair Thickness

  6 months

• Health-Related Quality of Life Questionnaire (HRQoL)

  6 months

Study Arms (2)

Oral Minoxidil Monotherapy Arm

Patients who were prescribed with low-dose oral minoxidil as monotherapy.

Drug: Oral low-dose Minoxidil

Oral Minoxidil + Nutraceutical Arm

Patients who were prescribed with low-dose oral minoxidil + nutraceutical

Drug: Oral low-dose Minoxidil; 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.

Interventions

Oral low-dose Minoxidil DRUG

Oral low-dose Minoxidil (0,5 - 1 mg)

Oral Minoxidil + Nutraceutical Arm; Oral Minoxidil Monotherapy Arm

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.

Oral Minoxidil + Nutraceutical Arm

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult women with a clinical diagnosis of female pattern hair loss (Ludwig or Olsen grade I) seen at the hair disorders unit of Instituto Médico Ricart, a dermatology clinic in Madrid, Spain. The cohort includes patients treated with low-dose oral minoxidil, alone or combined with a multifactorial drinkable nutraceutical, as part of routine clinical practice. To be included, patients had to have a baseline and a 6-month assessment with standardized phototrichoscopy.

You may qualify if:

• Women aged 20-50 years.
• Dermatologist-confirmed diagnosis (based on clinical and trichoscopic examination) of mild female androgenetic alopecia (FAGA) (Ludwig grade I or Olsen grade I), treated for at least 6 months with low-dose oral minoxidil (0.5-1 mg), either as monotherapy or in combination with Olistic® Women, between October 2023 and June 2026.
• Availability of TrichoScan imaging at baseline and after 6 months of treatment, together with a hair-shedding record after washing provided at the clinic visit and a questionnaire assessing psychological impact.

You may not qualify if:

• FAGA of a higher grade.
• Missing imaging, psychological questionnaire or hair-shedding collection at baseline or at 6 months.
• Concomitant treatment with any other drug (oral, topical or by mesotherapy) or any other food supplement during the 6-month study period.
• Substantial change in hair colour, hairstyle, or a marked haircut during the 6-month study period.
• Refusal to participate in the study.

Sponsors & Collaborators

• Olistic Research Labs S.L.: lead

Study Sites (1)

Clínica dermatológica IMR Madrid - Castellana

Madrid, Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil; Minerals; Plant Extracts

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Inorganic Chemicals; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 7, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 7, 2026

Record last verified: 2026-10

Locations

ES (1)