Skin Aging, Dry Skin
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTNP-2007
500mg/day, once a day, take 2 tablets with water.
DIETARY_SUPPLEMENTPlacebo
Take 2 tablets (matching NP-2007) once a day with water.
Sponsors
Hanpoong Nature Pharm Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy females between 35 and 65 years of age 2. Subjects with dry skin (Skin capacitance ≤ 49 units measured by Corneometer® CM 825) 3. Subjects with eye wrinkles (grade 3 or higher based on visual assessment scale) 4. Subjects who voluntarily signed the informed consent form after receiving a full explanation of the study 5. Subjects who are available for follow-up visits at scheduled times throughout the study period
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Skin Hydration at 12 weeks | Baseline, 6 weeks, 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. |
| Change from Baseline in Transepidermal Water Loss (TEWL) at 12 Weeks | Baseline, 6 weeks, 12 weeks | Measured using Tewameter® TM 300. The unit of measure is g/m²/h. Lower values indicate improved skin barrier function. |
| Change from Baseline in Skin Scaling at 12 Weeks | Baseline, 6 weeks, 12 weeks | Evaluated using D-Squame® and image analysis. Higher values indicate more scaling (worse), lower values indicate improvement. |
| Change from Baseline in Skin Roughness at 12 Weeks | Baseline, 6 weeks, 12 weeks | Measured using Visiometer® SV 700. Assesses the texture of the skin surface. Lower values indicate smoother skin. |
| Change from Baseline in Eye Wrinkles (Ra) at 12 Weeks | Baseline, 6 weeks, 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. |
| Change from Baseline in Skin Elasticity (R2) at 12 Weeks | Baseline, 6 weeks, 12 weeks | Measured using Cutometer® MPA 580. R2 represents gross elasticity (0 to 1 scale). Higher values indicate better skin elasticity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Visual Assessment Grade for Eye 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. | 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). |
| Participant Subjective Questionnaire Assessment for Skin Improvement | 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. | 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). |
Countries
South Korea
Outcome results
None listed