Telogen EffluviumNCT07111312
Clinical Evaluation of a Nutraceutical Supplement (Olistic Women) for Hair Growth and Hair Loss in Human Volunteers
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. in people with Telogen Effluvium, run by Olistic Research Labs S.L. at 2 sites in Spain.
Trial summary
Hair loss is a multifactorial and complex condition influenced by factors such as hormonal changes, vitamin and mineral deficiencies, genetic predisposition, oxidative stress, aging, inflammation, and psychological stress. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Telogen Effluvium
- 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.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 2 sitesSpain
- Study dates
- 10 Oct 2023to 23 Sep 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-40 years
- Sex: female
- Telogen effluvium diagnosis with hair loss > 100 hairs, confirmed using validated "modified wash test"
- Otherwise, healthy volunteers
- Refraining from systemic, topical, oral products with similar effects to the active product
- Signed informed consent
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- Maintenance of daily cosmetic and dietary routine
- Availability to attend all visits
- Compliance with all protocol requirements
Who cannot join
- Previous use of active product
- Participation in similar studies or usage of anti-hair loss products within the last 3 months
- History of dermatological treatment (e.g. mesotherapy) and/or hair transplant
- Skin or scalp diseases (e.g. psoriasis, dermatitis, alopecias)
- Alopecia secondary to medical diseases (e.g. hypothyroidism, anemia)
- Ongoing treatment for or diagnosis of systemic disease
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- Hormonal treatment (oral or topical contraceptives) within 6 months prior to study start
- Known allergy or intolerance, including to any of the ingredients of the active product
- Pregnancy, post-partum (6 months) or breastfeeding
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Placebo-controlled, Parallel, Randomized (1:1), Double-blind Study Over 6 Months to Evaluate the Efficacy and Safety of the Food Supplement Olistic Women.
Hair loss is a multifactorial and complex condition influenced by factors such as hormonal changes, vitamin and mineral deficiencies, genetic predisposition, oxidative stress, aging, inflammation, and psychological stress. This 6-month randomized, double-blind, placebo-controlled study aimed to evaluate the efficacy and safety of a drinkable nutraceutical formulated with natural, high-quality, patented, and standardized ingredients designed to support hair health through multiple biological pathways. A total of 106 premenopausal women aged 18 to 40 years and diagnosed with telogen effluvium were randomized to receive either the nutraceutical (n = 53) or placebo (n = 53). The primary endpoint was the increase in hair density from baseline versus placebo. The secondary endpoint was the change in the anagen-to-catagen/telogen (A:C/T) ratio. These parameters were assessed using phototrichoscopy and phototrichogram via TrichoScan®. The study was approved by an ethics committee and conducted by two independent board-certified dermatologists at two study sites.
- Conditions
- Telogen Effluvium
- 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., Placebo control
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.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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Product Arm | Active comparator | 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. |
| Placebo Arm | 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 temporoparietal area of the scalp.
Measured: From enrollment to the end of treatment at 180 days.
Secondary outcomes (1)
Change in the Anagen-to-Catagen/Telogen ratio
From phototrichogram on the temporoparietal area of the scalp.
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 posted8 Aug 2025
- Study start10 Oct 2023
- Primary completion10 May 2024
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Telogen EffluviumStudies 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
- 106 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
- NCT07111312
- Sponsor's protocol ID
- CT-OW-02
- Status last verified
- Dec 2025
- First submitted
- 31 Jul 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bernardez C, Podlipnik S, Westgate GE, Paus R, Zamfir L, Grohmann D, Saez Moya M. Efficacy and Safety of a Drinkable Nutraceutical in Premenopausal Women with Telogen Effluvium: A 6-Month, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2026 Jan;16(1):521-534. doi: 10.1007/s13555-025-01585-x. Epub 2025 Nov 25.
PubMed 41288927
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled, Parallel, Randomized (1:1), Double-blind Study Over 6 Months to Evaluate the Efficacy and Safety of the Food Supplement Olistic Women.
- ClinicalTrials.gov ID
- NCT07111312
- Acronym / sponsor ID
- CT-OW-02
- Conditions
- Telogen Effluvium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Olistic Research Labs S.L.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 23 Sep 2025 (actual)
- 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.
Hair loss is a multifactorial and complex condition influenced by factors such as hormonal changes, vitamin and mineral deficiencies, genetic predisposition, oxidative stress, aging, inflammation, and psychological stress. This 6-month randomized, double-blind, placebo-controlled study aimed to evaluate the efficacy and safety of a drinkable nutraceutical formulated with natural, high-quality, patented, and standardized ingredients designed to support hair health through multiple biological pathways. A total of 106 premenopausal women aged 18 to 40 years and diagnosed with telogen effluvium were randomized to receive either the nutraceutical (n = 53) or placebo (n = 53). The primary endpoint was the increase in hair density from baseline versus placebo. The secondary endpoint was the change in the anagen-to-catagen/telogen (A:C/T) ratio. These parameters were assessed using phototrichoscopy and phototrichogram via TrichoScan®. The study was approved by an ethics committee and conducted by two independent board-certified dermatologists at two study sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Product Arm | Active comparator | 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. |
| Placebo Arm | Placebo comparator | Other: Placebo control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age: 18-40 years
- Sex: female
- Telogen effluvium diagnosis with hair loss > 100 hairs, confirmed using validated "modified wash test"
- Otherwise, healthy volunteers
- Refraining from systemic, topical, oral products with similar effects to the active product
Key exclusion criteria (9 listed)
- Previous use of active product
- Participation in similar studies or usage of anti-hair loss products within the last 3 months
- History of dermatological treatment (e.g. mesotherapy) and/or hair transplant
- Skin or scalp diseases (e.g. psoriasis, dermatitis, alopecias)
- Alopecia secondary to medical diseases (e.g. hypothyroidism, anemia)
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.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 | Active Product Arm |
| 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 |
Primary outcome
Increase in hair density
Time frame: From enrollment to the end of treatment at 180 days.
From phototrichogram on the temporoparietal area of the scalp.
1 secondary outcome
Change in the Anagen-to-Catagen/Telogen ratio
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 11 Dec 2025.
- Derived from this study: PubMed 41288927Bernardez C, Podlipnik S, Westgate GE, Paus R, Zamfir L, Grohmann D, Saez Moya M. Efficacy and Safety of a Drinkable Nutraceutical in Premenopausal Women with Telogen Effluvium: A 6-Month, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2026 Jan;16(1):521-534. doi: 10.1007/s13555-025-01585-x. Epub 2025 Nov 25.
Related trials for Telogen Effluvium
Not yet recruitingObservational study
Gut Microbiota and Trichoscopic Changes in Women With Telogen Effluvium on a Multifactorial Drinkable Nutraceutical: A Retrospective Observational Study
Gut Dysbiosis, Telogen Effluvium
Recruiting
Efficacy and Safety of a Drinkable Nutraceutical for Hair Loss in Patients Using GLP-1/GIP Receptor Agonists
Telogen Effluvium
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Evaluation of the Dietary Supplement Effect on Improvement of Hair Condition in Subjects With Occasional Hair Loss.
Occasional Hair Loss
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Dietary Supplement for Telogen Effluvium Associated With GLP-1 Receptor Agonist Use
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Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth
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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.
2 sites 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, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women. in people with Telogen Effluvium, run by Olistic Research Labs S.L. at 2 sites 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 9 inclusion and 9 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 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
On the ClinicalTrials.gov record for NCT07111312, which also lists 1 linked publication.
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 11 Dec 2025.