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
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