Hair DamageNCT07458828
Evaluate the Efficacy and Safety of Hydrolyzed Keratin Peptide Powder on Hair Health
A study testing DAP-HAI-403 in people with Hair Damage and Hair Health, run by Dong-A Pharmaceutical at 1 site in South Korea.
Trial summary
This study is designed to evaluate the efficacy and safety of Hydrolyzed Keratin Peptide Powder in promoting hair health in adult with mild to moderate hair damage, compared to a placebo control. 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, Hair Health, Hair Strength
- What is being tested?
- DAP-HAI-403
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jan 2024to 12 Aug 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, aged 19 to 60 years
- Subjects with glossy scores between 1 and 3 points on the visual assessment classification and with a total hair damage score of less than 18 points based on exposure to risk factors
- Subjects who will refrain from perms or hair coloring, excluding haircuts, during the clinical study period
- Subjects who have agreed to participate in this clinical trial prior to its commencement and have signed the written informed consent form
Who cannot join
- Subjects with hair loss conditions such as androgenetic alopecia, alopecia areata, telogen effluvium, or cicatricial alopecia at Visit 1
- Subjects who have taken oral dutasteride or finasteride within 6 months prior to Visit 1
- Subjects who have consumed health functional foods (e.g., biotin) or general foods that may affect the human application study within 2 weeks prior to Visit 1
- Subjects who have applied topical steroid preparations to the scalp for one month prior to Visit 1
- Pregnancy or breastfeeding or planning pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Hydrolyzed Keratin Peptide Powder Improves Hair Quality and Scalp Barrier Function: A 24-Week Randomized, Double-Blind, Placebo-Controlled Trial
This study is designed to evaluate the efficacy and safety of Hydrolyzed Keratin Peptide Powder in promoting hair health in adult with mild to moderate hair damage, compared to a placebo control.
- Conditions
- Hair Damage, Hair Health, Hair Strength
- Being tested
- DAP-HAI-403, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAP-HAI-403Dietary supplement
Each subject takes two capsules per day for 24 weeks. Each capsule contains DAP-HAI-403 250mg.
PlaceboDietary supplement
Each subject takes two capsules per day for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DAP-HAI-403 | Experimental | 250mg/capsule (Hydrolyzed Keratin Peptide Powder 500mg/day) Receives: Dietary Supplement: DAP-HAI-403 |
| Placebo | Placebo comparator | 250 mg/capsule (500 mg/day as placebo) 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
Elasticity is measured using a Universal Testing Machine (UTM) at a stretching rate of 2 cm/min, and the mean tensile resistance prior to breakage was recorded. A higher score indicates a better outcome.
Measured: Change of the week 24 from baseline
The change of hair luster
Hair luster is evaluated using visual grading (5-point scale）, glossymeter （mean value ）, and scanning electron microscopy (SEM、 12-point scale ). Both visual grading and glossymeter indicate better outcomes with higher scores. For SEM, lower scores indicate better outcomes.
Measured: Change of the week 24 from baseline
The change of Self-evaluated satisfaction
Participants assessed their satisfaction of overall changes from baseline across 7 questions, rating perceived satisfaction on a 10-point scale (1 = not at all, 10 = very much).
Measured: Change of the week 24 from baseline
Secondary outcomes (6)
The change of Hair diameter
Hair diameter is evaluated by phototrichogram device (Folliscope 5.0) at 50× magnification. A higher score indicates a better outcome.
Measured: Change of the week 24 from baseline
The change of Hair density
Hair density is measured using Folliscope 5.0 at 14× magnification. A higher score indicates a better outcome.
Measured: Change of the week 24 from baseline
The change of Hair root volume
Hair root volume was quantified using I Max-plus image analysis software by measuring the angle (°) between the parting's origin and its highest lateral points-smaller angles after treatment indicated improved root lift and volume.
Measured: Change of the week 24 from baseline
The change of Scalp moisture
Scalp moisture is measured using the DermaLab Hydration Pin Probe. A higher score indicates a better outcome.
Measured: Change of the week 24 from baseline
The change of Scalp TEWL
Scalp TEWL is assessed using a Tewameter TM Nano. A lower score indicates better outcomes.
Measured: Change of the week 24 from baseline
The change of Self-improvement evaluation
Participants were asked to complete a self-evaluation questionnaire regarding their overall improvement in the study across 5 questions, rating perceived improvement on a 10-point scale (1 = no improvement, 10 = marked improvement).
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start23 Jan 2024
- Primary completion21 Jan 2025
- Study completion12 Aug 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Global Medical Research Center Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458828
- Sponsor's protocol ID
- DAP-HAI-403
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Mar 2026
- 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 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Hydrolyzed Keratin Peptide Powder Improves Hair Quality and Scalp Barrier Function: A 24-Week Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07458828
- Acronym / sponsor ID
- DAP-HAI-403
- Conditions
- Hair Damage, Hair Health, Hair Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dong-A PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Global Medical Research Center Co., Ltd.
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 9 Mar 2026 (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.
This study is designed to evaluate the efficacy and safety of Hydrolyzed Keratin Peptide Powder in promoting hair health in adult with mild to moderate hair damage, compared to a placebo control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAP-HAI-403 | Experimental | Dietary Supplement: DAP-HAI-403250mg/capsule (Hydrolyzed Keratin Peptide Powder 500mg/day) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo250 mg/capsule (500 mg/day as placebo) |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female, aged 19 to 60 years
- Subjects with glossy scores between 1 and 3 points on the visual assessment classification and with a total hair damage score of less than 18 points based on exposure to risk factors
- Subjects who will refrain from perms or hair coloring, excluding haircuts, during the clinical study period
- Subjects who have agreed to participate in this clinical trial prior to its commencement and have signed the written informed consent form
Key exclusion criteria (5 listed)
- Subjects with hair loss conditions such as androgenetic alopecia, alopecia areata, telogen effluvium, or cicatricial alopecia at Visit 1
- Subjects who have taken oral dutasteride or finasteride within 6 months prior to Visit 1
- Subjects who have consumed health functional foods (e.g., biotin) or general foods that may affect the human application study within 2 weeks prior to Visit 1
- Subjects who have applied topical steroid preparations to the scalp for one month prior to Visit 1
- Pregnancy or breastfeeding or planning pregnancy
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 |
|---|---|---|
| DAP-HAI-403Each subject takes two capsules per day for 24 weeks. Each capsule contains DAP-HAI-403 250mg. | Dietary supplement | DAP-HAI-403 |
| PlaceboEach subject takes two capsules per day for 24 weeks. | Dietary supplement | Placebo |
Primary outcome
The change of hair elasticity
Time frame: Change of the week 24 from baseline
Elasticity is measured using a Universal Testing Machine (UTM) at a stretching rate of 2 cm/min, and the mean tensile resistance prior to breakage was recorded. A higher score indicates a better outcome.
The change of hair luster
Time frame: Change of the week 24 from baseline
Hair luster is evaluated using visual grading (5-point scale）, glossymeter （mean value ）, and scanning electron microscopy (SEM、 12-point scale ). Both visual grading and glossymeter indicate better outcomes with higher scores. For SEM, lower scores indicate better outcomes.
The change of Self-evaluated satisfaction
Time frame: Change of the week 24 from baseline
Participants assessed their satisfaction of overall changes from baseline across 7 questions, rating perceived satisfaction on a 10-point scale (1 = not at all, 10 = very much).
6 secondary outcomes
The change of Hair diameter
Time frame: Change of the week 24 from baseline
The change of Hair density
Time frame: Change of the week 24 from baseline
The change of Hair root volume
Time frame: Change of the week 24 from baseline
The change of Scalp moisture
Time frame: Change of the week 24 from baseline
The change of Scalp TEWL
Time frame: Change of the week 24 from baseline
The change of Self-improvement evaluation
Time frame: Week 24
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 9 Mar 2026.
- 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 DAP-HAI-403 in people with Hair Damage and Hair Health, run by Dong-A Pharmaceutical 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 5 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 9 Mar 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 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 3 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 9 Mar 2026.