Early Female Pattern Hair Loss (FPHL)NCT07111299

Clinical Evaluation of a Nutraceutical Supplement for Hair Growth, Hair Loss and Skin Improvement in Human Volunteers Versus Placebo

A study testing Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women over 35 years. and Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women 18-35 years. in people with Early Female Pattern Hair Loss (FPHL), run by Olistic Research Labs S.L. at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The purpose of this clinical trial is to evaluate the efficacy and safety of Olistic Next Women, a nutraceutical supplement, in women experiencing beginning of FPHL. This 6-month, double-blind, placebo-controlled, 1:1 randomized clinical trial investigates whether daily supplementation with Olistic Women or Olistic… Read more about this study

Who is it for?: Ages 18 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, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women over 35 years. and Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women 18-35 years.
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteSpain
Study dates: 13 Oct 2025to Mar 2027
Phase: Interventional
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 18 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women aged 18-65.
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

Allergy or reactivity to some of the components of the product, or a product with similar category than tested one.
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).

Show all 20Show fewer

Women with thyroid alteration (hyper- or hypothyroidism)
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.
Pregnant, postpartum (6 months) or breastfeeding women, or who intend to get pregnant during the duration of the study.
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 customer.
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.

Spain1 site

Bionos Biotech Clínica
Valencia

Other trials in Spain

About this study

Official title: Clinical Evaluation of Hair Loss, Hair Growth, and Skin Improvement in Human Volunteers Following a Double-blind, Placebo-controlled, 1:1 Randomized Trial 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 experiencing beginning of FPHL.

This 6-month, double-blind, placebo-controlled, 1:1 randomized clinical trial investigates whether daily supplementation with Olistic Women or Olistic Next Women leads to significant improvements in hair parameters compared to placebo. 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, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women over 35 years., Placebo Control, Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women 18-35 years.

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, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women over 35 years.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. Target population: women aged >35. Not recommended during pregnancy or breastfeeding.
Placebo ControlOther
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.
Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women 18-35 years.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. Target population: women aged 18-35. Not recommended during pregnancy or breastfeeding.

Study groups in NCT07111299
Study group	Role	What they receive
Active Product Arm - Olistic Next Women	Experimental	Not described Receives: 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 over 35 years.
Placebo Arm - Olistic Next Women	Placebo comparator	Not described Receives: Other: Placebo Control
Active Product Arm - Olistic Women	Experimental	Not described Receives: 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 18-35 years.
Placebo Arm - Olistic Women	Placebo comparator	Not described Receives: Other: Placebo Control

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 Sagittal midline 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.

13 Oct 2025Mar 2027

First posted8 Aug 2025
Study start13 Oct 2025
Primary completionJan 2027 (estimated)
Study completionMar 2027 (estimated)

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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07111299
Sponsor's protocol ID: CT-ON-03
Status last verified: Dec 2025
First submitted: 31 Jul 2025
Last updated: 23 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Clinical Evaluation of a Nutraceutical Supplement for Hair Growth, Hair Loss and Skin Improvement in Human Volunteers
Early Female Pattern Hair Loss (FPHL)

All Early Female Pattern Hair Loss (FPHL) trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Hair Loss, Hair Growth, and Skin Improvement in Human Volunteers Following a Double-blind, Placebo-controlled, 1:1 Randomized Trial of 'Olistic Next Women'
ClinicalTrials.gov ID: NCT07111299
Acronym / sponsor ID: CT-ON-03
Conditions: Early Female Pattern Hair Loss (FPHL)
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Olistic Research Labs S.L.Industry (pharma, biotech, devices)
Study start: 13 Oct 2025 (actual)
Primary completion: Jan 2027 (estimated)
Study completion: Mar 2027 (estimated)
First posted: 8 Aug 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 experiencing beginning of FPHL.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Active Product Arm - Olistic Next Women	Experimental	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 over 35 years.
Placebo Arm - Olistic Next Women	Placebo comparator	Other: Placebo Control
Active Product Arm - Olistic Women	Experimental	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 18-35 years.
Placebo Arm - Olistic Women	Placebo comparator	Other: Placebo Control

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Women aged 18-65.
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 (20 listed)

Allergy or reactivity to some of the components of the product, or a product with similar category than tested one.
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.).

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, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women over 35 years.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. Target population: women aged >35. Not recommended during pregnancy or breastfeeding.	Dietary supplement	Active Product Arm - Olistic Next Women
Placebo ControlDrinkable 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.	Other	Placebo Arm - Olistic Next Women, Placebo Arm - Olistic Women
Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women 18-35 years.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. Target population: women aged 18-35. Not recommended during pregnancy or breastfeeding.	Dietary supplement	Active Product Arm - Olistic Women

Primary outcome

Increase in hair density
Time frame: From enrollment to the end of treatment at 180 days.
From phototrichogram on the Sagittal midline 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

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 23 Jul 2026.

Related trials for Early Female Pattern Hair Loss (FPHL)

Active, not recruiting
Clinical Evaluation of a Nutraceutical Supplement for Hair Growth, Hair Loss and Skin Improvement in Human Volunteers
Early Female Pattern Hair Loss (FPHL)

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?

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 20 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: under way, not looking for participants, as of the sponsor's last update on 23 Jul 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. Some participants in this study may receive a placebo. 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?

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?

On the ClinicalTrials.gov record for NCT07111299.

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 23 Jul 2026.