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

NCT07458828 | Completed

• 1 other identifier: DAP-HAI-403
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hair Damage; Hair Health; Hair Strength

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  Change of the week 24 from baseline

Secondary Outcomes (6)

• The change of Hair diameter

  Change of the week 24 from baseline

• The change of Hair density

  Change of the week 24 from baseline

• The change of Hair root volume

  Change of the week 24 from baseline

• The change of Scalp moisture

  Change of the week 24 from baseline

• The change of Scalp TEWL

  Change of the week 24 from baseline

Study Arms (2)

DAP-HAI-403

EXPERIMENTAL

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

Dietary Supplement: DAP-HAI-403

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

DAP-HAI-403 DIETARY_SUPPLEMENT

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

DAP-HAI-403

Placebo DIETARY_SUPPLEMENT

Each subject takes two capsules per day for 24 weeks.

Placebo

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A Pharmaceutical: lead
• Global Medical Research Center Co., Ltd.: collaborator

Study Sites (1)

Global Medical Research Center Co., Ltd.

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: March 9, 2026
• Study Start: January 23, 2024
• Primary Completion: January 21, 2025
• Study Completion: August 12, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)