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Completed

NCT Number: NCT07458828

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

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.

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Key information

Conditions

Hair Damage Hair Health Hair Strength

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Global Medical Research Center Co., Ltd.

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DAP-HAI-403

Dietary Supplement

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

Placebo

Dietary Supplement

Each subject takes two capsules per day for 24 weeks.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. The change of Hair diameter

    Time frame: Change of the week 24 from baseline

    Hair diameter is evaluated by phototrichogram device (Folliscope 5.0) at 50× magnification. A higher score indicates a better outcome.

  2. The change of Hair density

    Time frame: Change of the week 24 from baseline

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

  3. The change of Hair root volume

    Time frame: Change of the week 24 from baseline

    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.

  4. The change of Scalp moisture

    Time frame: Change of the week 24 from baseline

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

  5. The change of Scalp TEWL

    Time frame: Change of the week 24 from baseline

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

  6. The change of Self-improvement evaluation

    Time frame: Week 24

    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).

Sponsors and collaborators

Lead sponsor

Dong-A Pharmaceutical

Industry

Collaborators

  • Global Medical Research Center Co., Ltd.

Registry information

Official study title

Oral Hydrolyzed Keratin Peptide Powder Improves Hair Quality and Scalp Barrier Function: A 24-Week Randomized, Double-Blind, Placebo-Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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