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CompletedNCT07458828Updated Mar 9, 2026

Evaluate the Efficacy and Safety of Hydrolyzed Keratin Peptide Powder on Hair Health

An interventional study of DAP-HAI-403 and Placebo in Hair Damage, Hair Health and Hair Strength, sponsored by Dong-A Pharmaceutical. Completed at 1 site in South Korea. Open to participants aged 19 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by Dong-A Pharmaceutical · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Jan 2024, registered Feb 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
19 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hair Damage
  • Hair Health
  • Hair Strength
03

In context

Lead sponsor

Dong-A Pharmaceutical is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    DAP-HAI-403

    250mg/capsule (Hydrolyzed Keratin Peptide Powder 500mg/day)

    Dietary Supplement: DAP-HAI-403

  • Placebo comparator
    Placebo

    250 mg/capsule (500 mg/day as placebo)

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementDAP-HAI-403

    Each subject takes two capsules per day for 24 weeks. Each capsule contains DAP-HAI-403 250mg.

  • Dietary supplementPlacebo

    Each subject takes two capsules per day for 24 weeks.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change of the week 24 from baseline

  2. 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.

    Time frame: Change of the week 24 from baseline

  3. 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).

    Time frame: Change of the week 24 from baseline

Secondary outcomes

  1. 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.

    Time frame: Change of the week 24 from baseline

  2. The change of Hair density

    Hair density is measured using Folliscope 5.0 at 14× magnification. A higher score indicates a better outcome.

    Time frame: Change of the week 24 from baseline

  3. 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.

    Time frame: Change of the week 24 from baseline

  4. The change of Scalp moisture

    Scalp moisture is measured using the DermaLab Hydration Pin Probe. A higher score indicates a better outcome.

    Time frame: Change of the week 24 from baseline

  5. The change of Scalp TEWL

    Scalp TEWL is assessed using a Tewameter TM Nano. A lower score indicates better outcomes.

    Time frame: Change of the week 24 from baseline

  6. 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).

    Time frame: Week 24

07

Study locations

1 site
  • Global Medical Research Center Co., Ltd.
    Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07458828
Lead sponsor
Dong-A Pharmaceutical
Collaborators
Global Medical Research Center Co., Ltd.
Responsible party
Sponsor
First posted
Mar 9, 2026
Start date
Jan 23, 2024
Primary completion
Jan 21, 2025
Completion
Aug 12, 2025
Last update
Mar 9, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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