Female Pattern Hair LossNCT07862374
Oral Minoxidil With or Without a Multifactorial Drinkable Nutraceutical in Female Pattern Hair Loss: a Retrospective Study
An observational study of Female Pattern Hair Loss and Female Pattern Hair Loss, Androgenic Alopecia, run by Olistic Research Labs S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
- What is being tested?
- Oral low-dose Minoxidil and Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
- Substantial change in hair colour, hairstyle, or a marked haircut during the 6-month study period.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Clínica dermatológica IMR Madrid - Castellana
Madrid, Madrid, 28046
Alba Gómez-Zubiaur, 034910603150, a.gomez@imricart.com
Alba Gómez-Zubiaur, M.D., Ph.D.
About this study
Official title: Efficacy of a Multifactorial Drinkable Nutraceutical Combined With Oral Minoxidil Versus Oral Minoxidil Monotherapy in FPHL: A 6-Month Retrospective Observational Study
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.
- Being tested
- Oral low-dose Minoxidil, Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral low-dose MinoxidilDrug
Oral 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Minoxidil Monotherapy Arm | Patients who were prescribed with low-dose oral minoxidil as monotherapy. Receives: Drug: Oral low-dose Minoxidil | |
| Oral Minoxidil + Nutraceutical Arm | Patients who were prescribed with low-dose oral minoxidil + nutraceutical Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triple and Bigger Follicular Units
Change in triple and bigger follicular units analyzed via phototrichoscopy.
Measured: 6 months
Secondary outcomes (3)
Single and Double Follicular Units
Change in single and double follicular units analyzed via phototrichoscopy.
Measured: 6 months
Average Hair Thickness
Change in hair shaft diameter analyzed via phototrichoscopy.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Pattern Hair LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olistic Research Labs S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862374
- Sponsor's protocol ID
- CT-OW-03
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Multifactorial Drinkable Nutraceutical Combined With Oral Minoxidil Versus Oral Minoxidil Monotherapy in FPHL: A 6-Month Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07862374
- Acronym / sponsor ID
- CT-OW-03
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Olistic Research Labs S.L.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Minoxidil Monotherapy Arm | – | Drug: Oral low-dose MinoxidilPatients who were prescribed with low-dose oral minoxidil as monotherapy. |
| Oral Minoxidil + Nutraceutical Arm | – | 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.Patients who were prescribed with low-dose oral minoxidil + nutraceutical |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
- Substantial change in hair colour, hairstyle, or a marked haircut during the 6-month study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral low-dose MinoxidilOral low-dose Minoxidil (0,5 - 1 mg) | Drug | 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.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. | Dietary supplement | Oral Minoxidil + Nutraceutical Arm |
Primary outcome
Triple and Bigger Follicular Units
Time frame: 6 months
Change in triple and bigger follicular units analyzed via phototrichoscopy.
3 secondary outcomes
Single and Double Follicular Units
Time frame: 6 months
Average Hair Thickness
Time frame: 6 months
Health-Related Quality of Life Questionnaire (HRQoL)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Pattern Hair Loss and Female Pattern Hair Loss, Androgenic Alopecia, run by Olistic Research Labs S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triple and Bigger Follicular Units (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.