Efficacy and Safety of NP-2007 on Skin Health

March 17, 2026 updated by: Hanpoong Nature Pharm Co., Ltd.

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

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, South Korea
        • Corederm Skin Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Actual)

July 15, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

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

No

Studies a U.S. FDA-regulated device product

No

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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