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The objective of this study is to evaluate the efficacy and safety of Small-molecular-weight deer antler collagen (NP-2007) on skin health, including skin hydration, transepidermal water loss (TEWL), elasticity, and eye wrinkles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NP-2007 | Experimental | 500mg/day, once a day, take 2 tablets with water. |
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| Placebo | Placebo Comparator | Take 2 tablets (matching NP-2007) once a day with water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NP-2007 | Dietary Supplement | 500mg/day, once a day, take 2 tablets with water. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Skin Hydration at 12 weeks | Measured using Corneometer® CM 825. The unit of measure is arbitrary units (AU) ranging from 0 to 120. Higher scores indicate improved skin moisture. | Baseline, 6 weeks, 12 weeks |
| Change from Baseline in Transepidermal Water Loss (TEWL) at 12 Weeks | Measured using Tewameter® TM 300. The unit of measure is g/m²/h. Lower values indicate improved skin barrier function. | Baseline, 6 weeks, 12 weeks |
| Change from Baseline in Skin Scaling at 12 Weeks | Evaluated using D-Squame® and image analysis. Higher values indicate more scaling (worse), lower values indicate improvement. | Baseline, 6 weeks, 12 weeks |
| Change from Baseline in Skin Roughness at 12 Weeks | Measured using Visiometer® SV 700. Assesses the texture of the skin surface. Lower values indicate smoother skin. | Baseline, 6 weeks, 12 weeks |
| Change from Baseline in Eye Wrinkles (Ra) at 12 Weeks | Quantitative analysis of eye wrinkles (crow's feet) using Visiometer® SV 700. Ra represents the average roughness in millimeters (mm). Lower values indicate improved wrinkle depth. | Baseline, 6 weeks, 12 weeks |
| Change from Baseline in Skin Elasticity (R2) at 12 Weeks | Measured using Cutometer® MPA 580. R2 represents gross elasticity (0 to 1 scale). Higher values indicate better skin elasticity. | Baseline, 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Visual Assessment Grade for Eye Wrinkles | Baseline, 6 weeks, 12 weeks Clinical grading of eye wrinkle severity by a dermatologist using a visual analog scale. The scale ranges from 0 to 9, where 0 indicates 'None' (no wrinkles) and 9 indicates 'Very Severe' wrinkles. A decrease in the score (lower values) represents a better outcome (improvement in wrinkles). | Clinical grading of eye wrinkle severity by a dermatologist. The grade is based on a visual scale from 0 to 9 (0 = None, 9 = Very Severe). Lower grades indicate clinical improvement in wrinkle severity. |
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Inclusion Criteria:
Exclusion Criteria:
1) Subjects with skin diseases (atopic dermatitis, psoriasis, etc.) in the test area
2) Subjects who have used skin-related medications (steroids, etc.) within 1 month
3) Subjects with a history of hypersensitivity to the test ingredients or severe food allergies
4) Pregnant or lactating women, or those planning to become pregnant
5) Subjects who have participated in other clinical trials within the past 3 months
6) Any other conditions that the investigator deems unsuitable for participation
Only female participants are included in this study as the evaluation of skin aging parameters (e.g., crow's feet wrinkles) was specifically targeted at the female population based on the study protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corederm Skin Research Center | Seoul | South Korea |
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| Placebo |
| Dietary Supplement |
Take 2 tablets (matching NP-2007) once a day with water. |
|
| Participant Subjective Questionnaire Assessment for Skin Improvement | 6 weeks, 12 weeks Participants' self-assessment of skin improvement using a 5-point Likert scale. The scale ranges from 1 to 5, where 1 indicates 'Very Dissatisfied' and 5 indicates 'Very Satisfied'. A higher score represents a better outcome (higher satisfaction and perceived efficacy). | Participants assess skin improvement and satisfaction through a self-report questionnaire using a 5-point Likert scale (1 = Very Dissatisfied, 5 = Very Satisfied). Higher scores indicate greater satisfaction with the product's efficacy. |