- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07486414
Efficacy and Safety of NP-2007 on Skin Health
A 12-week, Randomized, Double-Blind, Placebo-Controlled Human Clinical Study to Evaluate the Efficacy and Safety of Small-Molecular-Weight Deer Antler Collagen (NP-2007) for Improving Skin Health
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, South Korea
- Corederm Skin Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy females between 35 and 65 years of age
- Subjects with dry skin (Skin capacitance ≤ 49 units measured by Corneometer® CM 825)
- Subjects with eye wrinkles (grade 3 or higher based on visual assessment scale)
- Subjects who voluntarily signed the informed consent form after receiving a full explanation of the study
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NP-2007
500mg/day, once a day, take 2 tablets with water.
|
500mg/day, once a day, take 2 tablets with water.
|
|
Placebo Comparator: Placebo
Take 2 tablets (matching NP-2007) once a day with water.
|
Take 2 tablets (matching NP-2007) once a day with water.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Skin Hydration at 12 weeks
Time Frame: 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.
|
Baseline, 6 weeks, 12 weeks
|
|
Change from Baseline in Transepidermal Water Loss (TEWL) at 12 Weeks
Time Frame: 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.
|
Baseline, 6 weeks, 12 weeks
|
|
Change from Baseline in Skin Scaling at 12 Weeks
Time Frame: Baseline, 6 weeks, 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
Time Frame: Baseline, 6 weeks, 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
Time Frame: 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.
|
Baseline, 6 weeks, 12 weeks
|
|
Change from Baseline in Skin Elasticity (R2) at 12 Weeks
Time Frame: Baseline, 6 weeks, 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Investigator's Visual Assessment Grade for Eye Wrinkles
Time Frame: 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).
|
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.
|
|
Participant Subjective Questionnaire Assessment for Skin Improvement
Time Frame: 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).
|
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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NP2007_HPN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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