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| Name | Class |
|---|---|
| Novarex | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Keranat™ | Experimental | Keranat™ capsule will be administered orally twice daily for 24 weeks. |
|
| Placebo | Placebo Comparator | Placebo capsule will be administered orally twice daily for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Keranat™ | Dietary Supplement | 300 mg/capsule(proso millet and wheat extract 600 mg/day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The change of anagen hair ratio(%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KSRC Korean Skin Research Center | Seongnam-si | Gyeonggido | 11234 | South Korea |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2023 | Jan 24, 2024 | Prot_SAP_000.pdf |
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| placebo |
| Dietary Supplement |
300 mg/capsule(600 mg/day as placebo) |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| The change of serum levels of cytokines (IL-1, TNF-α, 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 |