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

Hair Damage Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06237959
• Other study ID #: NC07-NOVA-2022
• Status: Completed
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: December 11, 2023

Study information

• Verified date: January 2024
• Source: Nutracore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 11, 2023
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hair Damage

Intervention

Dietary Supplement:
• Keranat™
300 mg/capsule(proso millet and wheat extract 600 mg/day)
• placebo
300 mg/capsule(600 mg/day as placebo)

Locations

Country	Name	City	State
Korea, Republic of	KSRC Korean Skin Research Center	Seongnam-si	Gyeonggido

Sponsors (2)

Lead Sponsor	Collaborator
Nutracore	Novarex

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The change of hair thickness	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.	Change of the week 24 from baseline
Secondary	The change of anagen hair ratio(%)	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.	Change of the week 24 from baseline
Secondary	The change in hair loss amount	To evaluate the change in the number of hair loss between the Keranat™ and placebo group. Collected and counted the number of lost hair.	Change of the week 24 from baseline
Secondary	The change of number of hair per unit area	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.	Change of the week 24 from baseline
Secondary	The change of hair distribution score through clinical photography	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.	Change of the week 24 from baseline
Secondary	Self-reported Hair health assessments	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.	Change of the week 24 from baseline
Secondary	The change of serum levels of cytokines (IL-1, TNF-a, PGE2)	To evaluate the change in serum levels of cytokines through clinical photography between the Keranat™ and placebo group.	Change of the week 24 from baseline