About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Treatment with FAGA-specific drugs (by any route of administration) within the 6 months prior to study inclusion.
Trial 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.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Oral low-dose Minoxidil
DrugOral low-dose Minoxidil (0,5 - 1 mg)
Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.
Dietary supplementDrinkable 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.
Treatment groups
Trial outcomes
Primary outcomes
Triple and Bigger Follicular Units
Change in triple and bigger follicular units analyzed via phototrichoscopy.
Secondary outcomes
Single and Double Follicular Units
Change in single and double follicular units analyzed via phototrichoscopy.
Average Hair Thickness
Change in hair shaft diameter analyzed via phototrichoscopy.
Health-Related Quality of Life Questionnaire (HRQoL)
A HRQoL questionnaire (Hair-Specific Skindex-29 / HSS-29) was used to assess three different spheres: emotions, functionality and symptoms.
Sponsors and contacts
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