Hair DamageNCT06237959
Evaluate the Efficacy and Safety of Proso Millet and Wheat Extract(Keranat™) on Hair Health
A study testing Keranat™ in people with Hair Damage, run by Nutracore at 1 site in South Korea.
Trial summary
The purpose of this randomized, double-blind, placebo-controlled study will be to evaluate whether the daily intake of Keranat™ for 24 weeks can promote the gloss and elasticity of hairs, improve their density and strength, and reduce hair loss. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hair Damage
- What is being tested?
- Keranat™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Nov 2022to 11 Dec 2023
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 19 and 60
- Hair gloss score of 3 or less and a hair damage score of less than 18 according to the visual evaluation classification method.
- Willing to maintain the same hairstyle, hair color, hair length, and hair regimen throughout the study period.
- Subject must be able to comprehend and voluntarily sign study procedures and consent forms.
Who cannot join
- Those diagnosed with and receiving treatment for the alopecia within 3 months before screening(androgenetic alopecia, alopecia areata, Telogen effluvium, etc.)
- Use of that may affect hair or hair loss symptoms treatment medicine, dietary supplements, or treatments containing herbal medicine ingredients within 3 months before screening.
- Any active scalp or skin disease that may interfere with the study treatment and evaluations.
- Pregnancy or breastfeeding or planning pregnancy
- Case of abnormal values at creatinine (excess at the upper limit of the reference range)
- Case of abnormal values at ALT or AST (2 times excess at the upper limit of the reference range)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
KSRC Korean Skin Research Center
Seongnam-si, Gyeonggido, 11234
About this study
Official title: A 24-Week, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Proso Millet and Wheat Extract(Keranat™) on Hair Health
The purpose of this randomized, double-blind, placebo-controlled study will be to evaluate whether the daily intake of Keranat™ for 24 weeks can promote the gloss and elasticity of hairs, improve their density and strength, and reduce hair loss.
- Conditions
- Hair Damage
- Being tested
- Keranat™, placebo
- Keywords
- Hair gloss, Hair elasticity, Hair strength, Hair thickness, Anagen hair, Number of hair loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keranat™Dietary supplement
300 mg/capsule(proso millet and wheat extract 600 mg/day)
placeboDietary supplement
300 mg/capsule(600 mg/day as placebo)
| Study group | Role | What they receive |
|---|---|---|
| Keranat™ | Experimental | Keranat™ capsule will be administered orally twice daily for 24 weeks. Receives: Dietary Supplement: Keranat™ |
| Placebo | Placebo comparator | Placebo capsule will be administered orally twice daily for 24 weeks. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of hair elasticity
To evaluate the change in hair elasticity between the Keranat™ and placebo group.
Hair elasticity was measured using an Expert 7601Tension Testing System.
Measured: Change of the week 24 from baseline
The change of hair gloss
To evaluate the change in hair gloss between the Keranat™ and placebo group. Hair gloss was measured using a Skin-Glossy meter GL200.
Measured: Change of the week 24 from baseline
Secondary outcomes (7)
The change of hair thickness
To evaluate the change in hair thickness improvement between the Keranat™ and placebo group. Hair thinness was assessed by measuring hair diameter using a microscope and ToupLite software.
Measured: Change of the week 24 from baseline
The change of anagen hair ratio(%)
To evaluate the change in the ratio of anagen hair between the Keranat™ and placebo group. Changes in Hair growth that occurred in the hair removal area for 3 days were analyzed using the Image-Pro® 10 program.
Measured: Change of the week 24 from baseline
The change in hair loss amount
To evaluate the change in the number of hair loss between the Keranat™ and placebo group. Collected and counted the number of lost hair.
Measured: Change of the week 24 from baseline
The change of number of hair per unit area
To evaluate the change in the number of hairs per unit area between the Keranat™ and placebo group. The number of hairs per unit area of the hair removal area was counted using Folliscope PS.
Measured: Change of the week 24 from baseline
The change of hair distribution score through clinical photography
To evaluate the change in hair distribution score through clinical photography between the Keranat™ and placebo group before and after intake. This evaluates improvement and deterioration on a 7-point scale, with higher scores meaning improvement. By comparing photos before and after intake, if there is no change, 0 points, improvement is a maximum of 3 points, and worsening is a minimum of -3 points.
Measured: Change of the week 24 from baseline
Self-reported Hair health assessments
To evaluate the change in Hair health improvement between the Keranat™ and placebo group. The evaluation was conducted through Patient Report Outcome(PRO) using a standardized survey form. Survey allowing for participant-report changes in hair health as a result of intervention using a 7-point scale.
Measured: Change of the week 24 from baseline
The change of serum levels of cytokines (IL-1, TNF-α, PGE2)
To evaluate the change in serum levels of cytokines through clinical photography between the Keranat™ and placebo group.
Measured: Change of the week 24 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start2 Nov 2022
- Primary completion12 Jun 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair DamageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutracore
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novarex
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237959
- Sponsor's protocol ID
- NC07-NOVA-2022
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 2 Feb 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 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-Week, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Proso Millet and Wheat Extract(Keranat™) on Hair Health
- ClinicalTrials.gov ID
- NCT06237959
- Acronym / sponsor ID
- NC07-NOVA-2022
- Conditions
- Hair Damage
- Keywords
- Hair gloss, Hair elasticity, Hair strength, Hair thickness, Anagen hair, Number of hair loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NutracoreIndustry (pharma, biotech, devices)
- Collaborators
- Novarex
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 2 Feb 2024 (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 randomized, double-blind, placebo-controlled study will be to evaluate whether the daily intake of Keranat™ for 24 weeks can promote the gloss and elasticity of hairs, improve their density and strength, and reduce hair loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keranat™ | Experimental | Dietary Supplement: Keranat™Keranat™ capsule will be administered orally twice daily for 24 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: placeboPlacebo capsule will be administered orally twice daily for 24 weeks. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 19 and 60
- Hair gloss score of 3 or less and a hair damage score of less than 18 according to the visual evaluation classification method.
- Willing to maintain the same hairstyle, hair color, hair length, and hair regimen throughout the study period.
- Subject must be able to comprehend and voluntarily sign study procedures and consent forms.
Key exclusion criteria (6 listed)
- Those diagnosed with and receiving treatment for the alopecia within 3 months before screening(androgenetic alopecia, alopecia areata, Telogen effluvium, etc.)
- Use of that may affect hair or hair loss symptoms treatment medicine, dietary supplements, or treatments containing herbal medicine ingredients within 3 months before screening.
- Any active scalp or skin disease that may interfere with the study treatment and evaluations.
- Pregnancy or breastfeeding or planning pregnancy
- Case of abnormal values at creatinine (excess at the upper limit of the reference range)
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 |
|---|---|---|
| Keranat™300 mg/capsule(proso millet and wheat extract 600 mg/day) | Dietary supplement | Keranat™ |
| placebo300 mg/capsule(600 mg/day as placebo) | Dietary supplement | Placebo |
Primary outcome
The change of hair elasticity
Time frame: Change of the week 24 from baseline
To evaluate the change in hair elasticity between the Keranat™ and placebo group. Hair elasticity was measured using an Expert 7601Tension Testing System.
The change of hair gloss
Time frame: Change of the week 24 from baseline
To evaluate the change in hair gloss between the Keranat™ and placebo group. Hair gloss was measured using a Skin-Glossy meter GL200.
7 secondary outcomes
The change of hair thickness
Time frame: Change of the week 24 from baseline
The change of anagen hair ratio(%)
Time frame: Change of the week 24 from baseline
The change in hair loss amount
Time frame: Change of the week 24 from baseline
The change of number of hair per unit area
Time frame: Change of the week 24 from baseline
The change of hair distribution score through clinical photography
Time frame: Change of the week 24 from baseline
Self-reported Hair health assessments
Time frame: Change of the week 24 from baseline
The change of serum levels of cytokines (IL-1, TNF-α, PGE2)
Time frame: Change of the week 24 from baseline
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 2 Feb 2024.
- Individual participant dataSharing planned: No
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 Keranat™ in people with Hair Damage, run by Nutracore at 1 site in South Korea.
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 4 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: finished, as of the sponsor's last update on 2 Feb 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 South Korea. 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?
The change of hair elasticity (time frame: Change of the week 24 from baseline). The study lists 2 primary outcomes in all. 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 2 Feb 2024.