Clinical trial NCT06237959: Evaluate the Efficacy and Safety of Proso Millet and Wheat Extract(Keranat™) on Hair Health
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Damage
Keywords: Hair gloss
Hair elasticity
Hair strength
Hair thickness
Anagen hair
Number of hair loss
Lead sponsor: Nutracore
Sponsor class: INDUSTRY
Collaborators: name: Novarex
First posted: 2024-02-02
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: The change of hair elasticity
timeFrame: Change of the week 24 from baseline
measure: The change of hair gloss
timeFrame: Change of the week 24 from baseline
Secondary outcomes:
measure: The change of hair thickness
timeFrame: Change of the week 24 from baseline
measure: The change of anagen hair ratio(%)
timeFrame: Change of the week 24 from baseline
measure: The change in hair loss amount
timeFrame: Change of the week 24 from baseline
measure: The change of number of hair per unit area
timeFrame: Change of the week 24 from baseline
measure: The change of hair distribution score through clinical photography
timeFrame: Change of the week 24 from baseline
measure: Self-reported Hair health assessments
timeFrame: Change of the week 24 from baseline
measure: The change of serum levels of cytokines (IL-1, TNF-α, PGE2)
timeFrame: Change of the week 24 from baseline
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: KSRC Korean Skin Research Center
state: Gyeonggido
Study officials:
References: