Early Female Pattern Hair Loss (FPHL)NCT07300228
Efficacy and Safety Evaluation of a Nutraceutical Supplement for Hair Growth, Hair Loss and Skin Improvement in Human Volunteers
A study testing Drinkable multifactorial food supplement containing vitamins, minerals, amino acids, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women +50. in people with Early Female Pattern Hair Loss (FPHL), run by Olistic Research Labs S.L. at 1 site in Spain.
Trial summary
The purpose of this clinical trial is to evaluate the efficacy and safety of Olistic Next Women, a nutraceutical supplement, in women diagnosed with early FPHL.This 6-month, open-label, interventional clinical trial investigates whether daily supplementation with Olistic Next Women leads to significant improvements in… Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Early Female Pattern Hair Loss (FPHL)
- What is being tested?
- Drinkable multifactorial food supplement containing vitamins, minerals, amino acids, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women +50.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSpain
- Study dates
- 16 Sep 2024to 23 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 50-65.
- 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.
Who cannot join
- 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)
Show all 19Show fewer
- 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.
- 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.
- Planned hairstyle changes throughout the study
- Presence of skin diseases or melanomas.
- Forecast of change of routine or relevant way of life, during the period of study.
- Other exclusion criteria to be added by the investigator.
- Allergy or reactivity to some of the components of the product, or a product with similar category than tested one.
- Women who have gone dermatological treatment, that they have introduced minoxidil (oral or topical) at least 6 months prior, and antiandrogens (e.g. finasteride) at least 12 months before the start of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Hair and Skin Health in Human Volunteers, Following a 6-month Open-label Interventional Study of 'Olistic Next Women'
The purpose of this clinical trial is to evaluate the efficacy and safety of Olistic Next Women, a nutraceutical supplement, in women diagnosed with early FPHL.This 6-month, open-label, interventional clinical trial investigates whether daily supplementation with Olistic Next Women leads to significant improvements in hair parameters. The study also monitors the tolerability and safety of the product throughout the intervention.
- Conditions
- Early Female Pattern Hair Loss (FPHL)
- Being tested
- Drinkable multifactorial food supplement containing vitamins, minerals, amino acids, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women +50.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drinkable multifactorial food supplement containing vitamins, minerals, amino acids, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women +50.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, amino acids, plant extracts, and other bioactive compounds designed to support hair growth and scalp health in women +50.
| Study group | Role | What they receive |
|---|---|---|
| Active Product Arm | Experimental | Not described Receives: Dietary Supplement: Drinkable multifactorial food supplement containing vitamins, minerals, amino acids, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women +50. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in hair density
From phototrichogram on the mid interparietal area of the scalp.
Measured: From enrollment to the end of treatment at 180 days.
Secondary outcomes (1)
Change in hair shedding
Hair shedding will be assessed by collecting shed hairs during a standardized washing and combing procedure.
Measured: From enrollment to the end of treatment at 180 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start16 Sep 2024
- Primary completion20 May 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Female Pattern Hair Loss (FPHL)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
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
- NCT07300228
- Sponsor's protocol ID
- CT-ON-01
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 12 Jan 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Hair and Skin Health in Human Volunteers, Following a 6-month Open-label Interventional Study of 'Olistic Next Women'
- ClinicalTrials.gov ID
- NCT07300228
- Acronym / sponsor ID
- CT-ON-01
- Conditions
- Early Female Pattern Hair Loss (FPHL)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Olistic Research Labs S.L.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 23 Dec 2025 (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.
The purpose of this clinical trial is to evaluate the efficacy and safety of Olistic Next Women, a nutraceutical supplement, in women diagnosed with early FPHL.This 6-month, open-label, interventional clinical trial investigates whether daily supplementation with Olistic Next Women leads to significant improvements in hair parameters. The study also monitors the tolerability and safety of the product throughout the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Product Arm | Experimental | Dietary Supplement: Drinkable multifactorial food supplement containing vitamins, minerals, amino acids, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women +50. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 50-65.
- 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.
Key exclusion criteria (19 listed)
- 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).
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 |
|---|---|---|
| Drinkable multifactorial food supplement containing vitamins, minerals, amino acids, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women +50.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, amino acids, plant extracts, and other bioactive compounds designed to support hair growth and scalp health in women +50. | Dietary supplement | Active Product Arm |
Primary outcome
Increase in hair density
Time frame: From enrollment to the end of treatment at 180 days.
From phototrichogram on the mid interparietal area of the scalp.
1 secondary outcome
Change in hair shedding
Time frame: From enrollment to the end of treatment at 180 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drinkable multifactorial food supplement containing vitamins, minerals, amino acids, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women +50. in people with Early Female Pattern Hair Loss (FPHL), 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 6 inclusion and 19 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: finished, as of the sponsor's last update on 12 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in hair density (time frame: From enrollment to the end of treatment at 180 days.). 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 12 Jan 2026.