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

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.

Study Overview

• Status: Completed
• Conditions: Hair Damage; Hair Health; Hair Strength
• Intervention / Treatment: Dietary supplement: DAP-HAI-403; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAP-HAI-403; 250mg/capsule (Hydrolyzed Keratin Peptide Powder 500mg/day)	Dietary supplement: DAP-HAI-403; Each subject takes two capsules per day for 24 weeks. Each capsule contains DAP-HAI-403 250mg.
Placebo Comparator: Placebo; 250 mg/capsule (500 mg/day as placebo)	Dietary supplement: Placebo; Each subject takes two capsules per day for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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).	Week 24

Collaborators and Investigators

• Sponsor: Dong-A Pharmaceutical
• Collaborators: Global Medical Research Center Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Actual): January 21, 2025
• Study Completion (Actual): August 12, 2025

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: DAP-HAI-403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No