Hair ThinningTO-HAIRNCT06174441
The Effect of 24-week Dietary Intake of Food Supplements on Hair
A study testing Investigational product 1 (CPMSM) and Investigational product 2 (HC+) in people with Hair Thinning and Hair Loss, run by VIST - Faculty of Applied Sciences at 1 site in Slovenia.
Trial summary
Purpose of this randomized, double-blind, placebo-controlled study will be to evaluate whether the daily use of novel dietary supplements over 24 weeks is able strengthen and promote growth of hairs, improve their density and thickness and reduce hair loss in adults with self-perceived thinning hair. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hair Thinning, Hair Loss
- What is being tested?
- Investigational product 1 (CPMSM) and Investigational product 2 (HC+)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteSlovenia
- Study dates
- 8 Jan 2024to 25 Oct 2024
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian volunteers of both sexes; aged 25-60 years at the time of the signature of Informed consent form (ICF).
- Darker (not blonde or grey) at least 5 cm long on midline.
- Signed Informed consent form (ICF).
- Fitzpatrick skin phototypes I-IV.
- Self-perceived hair thinning - subjects complaining of hair fall and damage.
- Derived Sinclair Scale score up to 3.
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- In good general health condition.
- Subjects who are not crash dieting.
- Willingness to maintain using regular hair care routine regarding hair washing and styling, hair dye / hair colour during the study period.
- Willingness to refrain from any type of hair treatment like perming, permanent straightening etc. during the study duration.
- Willingness to not substantially change their lifestyle, current diet, medications, or exercise routines for the duration of the study.
- Willingness to refrain from any other topical treatment/hair spa and oral medications or supplement for hair growth during the study.
- BMI < 35
- Willingness to avoid a consumption of any other food supplements containing methylsulfonylmethane (MSM), antioxidants, collagen or other protein-based food supplements, Pea sprout extract, Horsetail extract, Ashwagandha root extract, Saw palmetto fruit extract, Nettle leaves extract, Grape seed extract, biotin, zinc, niacin, pantothenic acid, vitamin B6, folic acid during the study.
- Willingness to follow all study procedures and keeping a diary during the study (to follow their compliance and palatability).
- Willingness not to begin or change any estrogen or progesterone or other hormonal therapies.
- Willingness of subjects who have color treated hair to have the color treatment performed at the same time interval prior to each visit.
- No known or suspected allergy to any ingredient of the tested products as established by medical history.
Who cannot join
- Pregnancy or breastfeeding or planning pregnancy in near future (in next year).
- Menopausal female subjects as determined by medical history.
- Recent initiation or change (<6 months) of hormones for birth control or hormone replacement therapy in females or other hormonal therapies.
- Use of treatments for hair growth treatment including minoxidil, finasteride or light therapy within the last 3 months or other medications that are known to cause hair loss or affect hair growth (eg. Cyproterone acetate, Aldactone/spironolactone, 5-alpha-reductase inhibitors, phenytoin) within the last 6 months.
- Subjects with any clinically significant history of underlying uncontrolled medical illness including thyroid disorders, diabetes mellitus, hypertension, cancer, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
- Changes in dietary habits and dietary supplementation in the last three months prior to inclusion.
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- Veganism.
- Regular use of food supplements containing methylsulfonylmethane (MSM), collagen or other protein-based food supplements, Pea sprout extract, Horsetail extract, Ashwagandha root extract, Saw palmetto fruit extract, Nettle leaves extract, Grape seed extract, or vitamin or antioxidant supplements, which will compromise the study, in the last three months prior to inclusion.
- Subjects having any active scalp or skin disease which may interfere with the study treatment and evaluations.
- Subjects who have had hair transplant.
- Subjects undergoing any chemical hair salon treatment-straightening / perming.
- Subjects participating in other similar cosmetic or therapeutic trial within last year.
- Subjects who have experienced a known stressful event within the last 6 months such as death in family, miscarriage etc.
- Known history or recent blood work indicating iron deficiency, bleeding disorders or platelet dysfunction syndrome.
- Smokers with usage > 20 cigarettes/day.
- Changes in hair care routine in the last month prior to inclusion,
- Mental incapacity that precludes adequate understanding or cooperation.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
VIST - Faculty of Applied Sciences, Institute of Cosmetics
Ljubljana, 1000
About this study
Official title: The Effect of 24-week Dietary Intake of Food Supplements on Hair: Double Blind, Placebo-controlled, Randomised Three-way Study to Assess Effectiveness of Two Test Products
Purpose of this randomized, double-blind, placebo-controlled study will be to evaluate whether the daily use of novel dietary supplements over 24 weeks is able strengthen and promote growth of hairs, improve their density and thickness and reduce hair loss in adults with self-perceived thinning hair.
Read the detailed description
Single centre, randomized, double-blind, placebo-controlled, one-period effectiveness study to evaluate whether the daily use of novel dietary supplements over 24 weeks will strengthen and promote density and quality of hair in adults with self-perceived thinning hair.
Study population will be divided in three groups - 32 in active groups and 20 in placebo group. Test group 1 (TG1) will receive investigational product 1 (CPMSM: containing fish collagen, methylsulphonylmethane (MSM), vitamins and zinc), test group 2 (TG2) will receive investigational product 2 (HC+: containing mixture of herbal extracts, B-vitamins and zinc) and the placebo group (PG) will receive placebo product without any of the active ingredients (PL, no active ingredients). Participants will test continuous administration of placebo or investigational products (in the form of syrups) for 24 weeks in order to demonstrate and assess multiple-dose effects.
- Conditions
- Hair Thinning, Hair Loss
- Being tested
- Investigational product 1 (CPMSM), Investigational product 2 (HC+), Placebo
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational product 1 (CPMSM)Dietary supplement
Test group 1 will receive investigational product 1 (CPMSM: daily dose 25 mL contains: Hydrolyzed fish collagen 5 g, methylsulphonylmethane (MSM) 1,5 g, Biotin 150 μg, Vitamin B6 1,6 mg, Zinc 2 mg, Vitamin C 120 mg).
Investigational product 2 (HC+)Dietary supplement
Test group 2 (TG2) will receive investigational product 2 (HC+: daily dose 25 mL contains: Niacin 16 mg, Pantothenic acid 6 mg, Biotin 500 μg, Vitamin B6 1,4 mg, Folic acid 200 μg, Zinc 2 mg, Pea sprout extract 100 mg, Horsetail aerial parts extract 70 mg, Ashwagandha root extract 40 mg, Saw palmetto fruit extract 40 mg, Nettle leaves extract 30 mg, Grape seed extract 10 mg).
PlaceboDietary supplement
Placebo group (PG) will receive placebo product without any of the active ingredients (PL, daily dose 25 mL: no active ingredients).
| Study group | Role | What they receive |
|---|---|---|
| Test group 1 (CPMSM) | Active comparator | Investigational product 1: daily dose 25 mL contains: Hydrolyzed fish collagen 5 g, methylsulphonylmethane (MSM) 1,5 g, Biotin 150 μg, Vitamin B6 1,6 mg, Zinc 2 mg, Vitamin C 120 mg. Receives: Dietary Supplement: Investigational product 1 (CPMSM) |
| Test group 2 (HC+) | Active comparator | Investigational product 2: daily dose 25 mL contains: Niacin 16 mg, Pantothenic acid 6 mg, Biotin 500 μg, Vitamin B6 1,4 mg, Folic acid 200 μg, Zinc 2 mg, Pea sprout extract 100 mg, Horsetail aerial parts extract 70 mg, Ashwagandha root extract 40 mg, Saw palmetto fruit extract 40 mg, Nettle leaves extract 30 mg, Grape seed extract 10 mg.
Intervention: Dietary Supplement: Placebo Placebo group (PG) will receive placebo product without any of the active ingredients (PL, daily dose 25 mL: no active ingredients). Receives: Dietary Supplement: Investigational product 2 (HC+) |
| Placebo group | Placebo comparator | placebo product without any of the active ingredients, daily dose 25 mL: no active ingredients. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of hair density from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
Significant change of hair density from baseline in test groups, in comparison to placebo group after 24 weeks of dietary supplementation with study products is expected. Hair density will be assessed through trichoscopy using H2H matching procedure. Results will be analysed for whole sample and separately for men and women.
Measured: 24-weeks
Secondary outcomes (4)
Change of scalp sebum from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
Significant change of scalp sebum from baseline in test groups, in comparison to placebo group after 24 weeks of dietary supplementation with study products is expected. Scalp sebum will be measured using DermaLab SkinLab sebum module.
Measured: 24 weeks
Change of hair thickness from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
Significant change of hair thickness from baseline in test groups, in comparison to placebo group after 24 weeks of dietary supplementation with study products is expected. Hair thickness will be assessed through trichoscopy using H2H matching procedure and average hair thickness determined.
Measured: 24-weeks
Change of hair loss from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
Significant change of hair loss from baseline in test groups, in comparison to placebo group after 24 weeks of dietary supplementation with study products is expected. Hair loss will be assessed through Hair comb test.
Measured: 24-weeks
Change of terminal hair density from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
Significant change of hair density from baseline in test groups, in comparison to placebo group after 24 weeks of dietary supplementation with study products is expected. Hair density will be assessed through trichoscopy using H2H matching procedure. Results will be analysed for whole sample and separately for men and women.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start8 Jan 2024
- Primary completion18 Jul 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair ThinningStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIST - Faculty of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Slovenian Research and Innovation Agency, Tosla d.o.o.
- Responsible party
- Sponsor
- Investigators
- Katja Žmitek, PhD, Study director, Head of research group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174441
- Sponsor's protocol ID
- VIST TO-HAIR 01-2023
- Acronym
- TO-HAIR
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2023
- Last updated
- 29 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 24-week Dietary Intake of Food Supplements on Hair: Double Blind, Placebo-controlled, Randomised Three-way Study to Assess Effectiveness of Two Test Products
- ClinicalTrials.gov ID
- NCT06174441
- Acronym / sponsor ID
- TO-HAIR / VIST TO-HAIR 01-2023
- Conditions
- Hair Thinning, Hair Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- VIST - Faculty of Applied SciencesUniversity, hospital or other
- Collaborators
- Slovenian Research and Innovation Agency, Tosla d.o.o.
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 18 Dec 2023 (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.
Purpose of this randomized, double-blind, placebo-controlled study will be to evaluate whether the daily use of novel dietary supplements over 24 weeks is able strengthen and promote growth of hairs, improve their density and thickness and reduce hair loss in adults with self-perceived thinning hair.
Detailed description
Single centre, randomized, double-blind, placebo-controlled, one-period effectiveness study to evaluate whether the daily use of novel dietary supplements over 24 weeks will strengthen and promote density and quality of hair in adults with self-perceived thinning hair.
Study population will be divided in three groups - 32 in active groups and 20 in placebo group. Test group 1 (TG1) will receive investigational product 1 (CPMSM: containing fish collagen, methylsulphonylmethane (MSM), vitamins and zinc), test group 2 (TG2) will receive investigational product 2 (HC+: containing mixture of herbal extracts, B-vitamins and zinc) and the placebo group (PG) will receive placebo product without any of the active ingredients (PL, no active ingredients). Participants will test continuous administration of placebo or investigational products (in the form of syrups) for 24 weeks in order to demonstrate and assess multiple-dose effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test group 1 (CPMSM) | Active comparator | Dietary Supplement: Investigational product 1 (CPMSM)Investigational product 1: daily dose 25 mL contains: Hydrolyzed fish collagen 5 g, methylsulphonylmethane (MSM) 1,5 g, Biotin 150 μg, Vitamin B6 1,6 mg, Zinc 2 mg, Vitamin C 120 mg. |
| Test group 2 (HC+) | Active comparator | Dietary Supplement: Investigational product 2 (HC+)Investigational product 2: daily dose 25 mL contains: Niacin 16 mg, Pantothenic acid 6 mg, Biotin 500 μg, Vitamin B6 1,4 mg, Folic acid 200 μg, Zinc 2 mg, Pea sprout extract 100 mg, Horsetail aerial parts extract 70 mg, Ashwagandha root extract 40 mg, Saw palmetto fruit extract 40 mg, Nettle leaves extract 30 mg, Grape seed extract 10 mg. Intervention: Dietary Supplement: Placebo Placebo group (PG) will receive placebo product without any of the active ingredients (PL, daily dose 25 mL: no active ingredients). |
| Placebo group | Placebo comparator | Dietary Supplement: Placeboplacebo product without any of the active ingredients, daily dose 25 mL: no active ingredients. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Caucasian volunteers of both sexes; aged 25-60 years at the time of the signature of Informed consent form (ICF).
- Darker (not blonde or grey) at least 5 cm long on midline.
- Signed Informed consent form (ICF).
- Fitzpatrick skin phototypes I-IV.
- Self-perceived hair thinning - subjects complaining of hair fall and damage.
Key exclusion criteria (17 listed)
- Pregnancy or breastfeeding or planning pregnancy in near future (in next year).
- Menopausal female subjects as determined by medical history.
- Recent initiation or change (<6 months) of hormones for birth control or hormone replacement therapy in females or other hormonal therapies.
- Use of treatments for hair growth treatment including minoxidil, finasteride or light therapy within the last 3 months or other medications that are known to cause hair loss or affect hair growth (eg. Cyproterone acetate, Aldactone/spironolactone, 5-alpha-reductase inhibitors, phenytoin) within the last 6 months.
- Subjects with any clinically significant history of underlying uncontrolled medical illness including thyroid disorders, diabetes mellitus, hypertension, cancer, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
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 |
|---|---|---|
| Investigational product 1 (CPMSM)Test group 1 will receive investigational product 1 (CPMSM: daily dose 25 mL contains: Hydrolyzed fish collagen 5 g, methylsulphonylmethane (MSM) 1,5 g, Biotin 150 μg, Vitamin B6 1,6 mg, Zinc 2 mg, Vitamin C 120 mg). | Dietary supplement | Test group 1 (CPMSM) |
| Investigational product 2 (HC+)Test group 2 (TG2) will receive investigational product 2 (HC+: daily dose 25 mL contains: Niacin 16 mg, Pantothenic acid 6 mg, Biotin 500 μg, Vitamin B6 1,4 mg, Folic acid 200 μg, Zinc 2 mg, Pea sprout extract 100 mg, Horsetail aerial parts extract 70 mg, Ashwagandha root extract 40 mg, Saw palmetto fruit extract 40 mg, Nettle leaves extract 30 mg, Grape seed extract 10 mg). | Dietary supplement | Test group 2 (HC+) |
| PlaceboPlacebo group (PG) will receive placebo product without any of the active ingredients (PL, daily dose 25 mL: no active ingredients). | Dietary supplement | Placebo group |
Primary outcome
Change of hair density from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
Time frame: 24-weeks
Significant change of hair density from baseline in test groups, in comparison to placebo group after 24 weeks of dietary supplementation with study products is expected. Hair density will be assessed through trichoscopy using H2H matching procedure. Results will be analysed for whole sample and separately for men and women.
4 secondary outcomes
Change of scalp sebum from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
Time frame: 24 weeks
Change of hair thickness from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
Time frame: 24-weeks
Change of hair loss from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
Time frame: 24-weeks
Change of terminal hair density from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
Time frame: 24 weeks
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 29 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Katja Žmitek, PhD study director
Head of research group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational product 1 (CPMSM) and Investigational product 2 (HC+) in people with Hair Thinning and Hair Loss, run by VIST - Faculty of Applied Sciences at 1 site in Slovenia.
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 18 inclusion and 17 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 29 Oct 2024. 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 Slovenia. 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?
Change of hair density from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation (time frame: 24-weeks). 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 29 Oct 2024.