Hair Damage
Conditions
Keywords
Hair gloss, Hair elasticity, Hair strength, Hair thickness, Anagen hair, Number of hair loss
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.
Interventions
DIETARY_SUPPLEMENTKeranat™
300 mg/capsule(proso millet and wheat extract 600 mg/day)
DIETARY_SUPPLEMENTplacebo
300 mg/capsule(600 mg/day as placebo)
Sponsors
Novarex
Nutracore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of hair elasticity | 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. |
| The change of hair gloss | 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
| Measure | Time frame | Description |
|---|---|---|
| The change in hair loss amount | 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. |
| The change of number of hair per unit area | 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. |
| The change of hair thickness | 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. |
| Self-reported Hair health assessments | 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. |
| The change of serum levels of cytokines (IL-1, TNF-α, PGE2) | 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. |
| The change of hair distribution score through clinical photography | 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. |
| The change of anagen hair ratio(%) | 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. |
Countries
South Korea
Outcome results
None listed