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Completed

NCT Number: NCT06237959

Evaluate the Efficacy and Safety of Proso Millet and Wheat Extract(Keranat™) on Hair Health

The purpose of this randomized, double-blind, placebo-controlled study will be to evaluate whether the daily intake of Keranat™ for 24 weeks can promote the gloss and elasticity of hairs, improve their density and strength, and reduce hair loss.

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Key information

Conditions

Hair Damage

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KSRC Korean Skin Research Center

Seongnam-si, Gyeonggido, 11234, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 19 and 60
  • Hair gloss score of 3 or less and a hair damage score of less than 18 according to the visual evaluation classification method.
  • Willing to maintain the same hairstyle, hair color, hair length, and hair regimen throughout the study period.
  • Subject must be able to comprehend and voluntarily sign study procedures and consent forms.

Exclusion criteria

  • Those diagnosed with and receiving treatment for the alopecia within 3 months before screening(androgenetic alopecia, alopecia areata, Telogen effluvium, etc.)
  • Use of that may affect hair or hair loss symptoms treatment medicine, dietary supplements, or treatments containing herbal medicine ingredients within 3 months before screening.
  • Any active scalp or skin disease that may interfere with the study treatment and evaluations.
  • Pregnancy or breastfeeding or planning pregnancy
  • Case of abnormal values at creatinine (excess at the upper limit of the reference range)
  • Case of abnormal values at ALT or AST (2 times excess at the upper limit of the reference range)

Treatment and study plan

Keranat™

Dietary Supplement

300 mg/capsule(proso millet and wheat extract 600 mg/day)

Placebo

Dietary Supplement

300 mg/capsule(600 mg/day as placebo)

Primary outcomes

  1. The change of hair elasticity

    Time frame: Change of the week 24 from baseline

    To evaluate the change in hair elasticity between the Keranat™ and placebo group.

    Hair elasticity was measured using an Expert 7601Tension Testing System.

  2. The change of hair gloss

    Time frame: Change of the week 24 from baseline

    To evaluate the change in hair gloss between the Keranat™ and placebo group. Hair gloss was measured using a Skin-Glossy meter GL200.

Secondary outcomes

  1. The change of hair thickness

    Time frame: Change of the week 24 from baseline

    To evaluate the change in hair thickness improvement between the Keranat™ and placebo group. Hair thinness was assessed by measuring hair diameter using a microscope and ToupLite software.

  2. The change of anagen hair ratio(%)

    Time frame: Change of the week 24 from baseline

    To evaluate the change in the ratio of anagen hair between the Keranat™ and placebo group. Changes in Hair growth that occurred in the hair removal area for 3 days were analyzed using the Image-Pro® 10 program.

  3. The change in hair loss amount

    Time frame: Change of the week 24 from baseline

    To evaluate the change in the number of hair loss between the Keranat™ and placebo group. Collected and counted the number of lost hair.

  4. The change of number of hair per unit area

    Time frame: Change of the week 24 from baseline

    To evaluate the change in the number of hairs per unit area between the Keranat™ and placebo group. The number of hairs per unit area of the hair removal area was counted using Folliscope PS.

  5. The change of hair distribution score through clinical photography

    Time frame: Change of the week 24 from baseline

    To evaluate the change in hair distribution score through clinical photography between the Keranat™ and placebo group before and after intake. This evaluates improvement and deterioration on a 7-point scale, with higher scores meaning improvement. By comparing photos before and after intake, if there is no change, 0 points, improvement is a maximum of 3 points, and worsening is a minimum of -3 points.

  6. Self-reported Hair health assessments

    Time frame: Change of the week 24 from baseline

    To evaluate the change in Hair health improvement between the Keranat™ and placebo group. The evaluation was conducted through Patient Report Outcome(PRO) using a standardized survey form. Survey allowing for participant-report changes in hair health as a result of intervention using a 7-point scale.

  7. The change of serum levels of cytokines (IL-1, TNF-α, PGE2)

    Time frame: Change of the week 24 from baseline

    To evaluate the change in serum levels of cytokines through clinical photography between the Keranat™ and placebo group.

Sponsors and collaborators

Lead sponsor

Nutracore

Industry

Collaborators

  • Novarex

Registry information

Official study title

A 24-Week, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Proso Millet and Wheat Extract(Keranat™) on Hair Health

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2024
Registry last updated
Feb 2, 2024

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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