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

NCT06237959 | Completed

• 1 other identifier: NC07-NOVA-2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hair Damage

Keywords

Hair gloss; Hair elasticity; Hair strength; Hair thickness; Anagen hair; Number of hair loss

Outcome Measures

Primary Outcomes (2)

• The change of hair elasticity

  To evaluate the change in hair elasticity between the Keranat™ and placebo group. Hair elasticity was measured using an Expert 7601Tension Testing System.

  Change of the week 24 from baseline

• The change of hair gloss

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

  Change of the week 24 from baseline

Secondary Outcomes (7)

• The change of hair thickness

  Change of the week 24 from baseline

• The change of anagen hair ratio(%)

  Change of the week 24 from baseline

• The change in hair loss amount

  Change of the week 24 from baseline

• The change of number of hair per unit area

  Change of the week 24 from baseline

• The change of hair distribution score through clinical photography

  Change of the week 24 from baseline

Study Arms (2)

Keranat™

EXPERIMENTAL

Keranat™ capsule will be administered orally twice daily for 24 weeks.

Dietary Supplement: Keranat™

Placebo

PLACEBO COMPARATOR

Placebo capsule will be administered orally twice daily for 24 weeks.

Dietary Supplement: placebo

Interventions

Keranat™ DIETARY_SUPPLEMENT

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

Keranat™

placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nutracore: lead
• Novarex: collaborator

Study Sites (1)

KSRC Korean Skin Research Center

Seongnam-si, Gyeonggido, 11234, South Korea

Location

Study Design

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

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: February 2, 2024
• Study Start: November 2, 2022
• Primary Completion: June 12, 2023
• Study Completion: December 11, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)