Efficacy and Safety of AP Collagen Peptide on the Skin

Study Overview
=================
Brief Summary
-----------------
This double-blinded, randomized, placebo-controlled study aimed to evaluate the efficacy and safety of AP collagen peptides (APCP) containing 3% Glycine-Proline-Hydroxyproline (GPH) on improving skin health. Subjects with dried skin were randomly assigned to receive placebo or APCP once daily for 12 weeks.

Official Title
-----------------
Evaluation of Skin Health Improvement and Safety in AP Collagen Peptide: Randomized, Double-blind, Placebo-controlled

Conditions
-----------------
Dry Skin

Intervention / Treatment
-----------------
* Dietary Supplement: AP collagen peptide
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those whose eye wrinkles are Grade 3 or higher in the visual evaluation Those whose moisture retention in both cheeks measured by Corneometer® is 49 A.U. or less A person who has agreed to participate in this human application test before the start of the human application test and filled out the Informed Consent Form Exclusion Criteria: Those with skin diseases such as atopic dermatitis and psoriasis Those who are sensitive to or allergic to the food ingredients for this trial foods Those with skin abnormalities such as spots, acne, erythema, and hypersensitive skin at the test site People who take diet pills (absorbent and antidepressants, appetite suppressants, etc.) and contraceptives or hormones or diuretics within one month based on visit1 Those who have used functional cosmetics for wrinkle improvement, highly moisturizing cosmetics, or skincare devices within 2 weeks of visit 1 A person who used steroid-containing outer skin for more than one month to treat skin diseases A person who has received chemical and physical treatment (pattern, epidermis, lasers, procedures, etc.) in the test area within six months prior to the start of the test Visit 1 A person who has participated in other interventional clinical tests (including human application tests) within one month of the standard or plans to participate in other interventional clinical tests (including human application tests) after the start of this human application test A person who judges that the tester is inappropriate for this test

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AP collagen peptide<br>Each subject takes one active bottle per day for 12 weeks. Each bottle contains AP collagen 1000 mg | Dietary Supplement: AP collagen peptide<br>* Health functional food<br>|
| Placebo Comparator: Placebo<br>Each subject takes one active bottle per day for 12 weeks. | Dietary Supplement: Placebo<br>* placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in epidermal hydration | skin hydration measured by MoistureMeter-D compact | Baseline, 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in skin roughness (texture) | skin roughness measured by PRIMOS | Baseline, 12 week | 
| Change from baseline in skin gloss | skin roughness measured by Skinglossmeter | Baseline, 12 week | 
| Change from baseline in stratum corneum condition | stripped using 10 tape strips (D-Squame) and measured by VisioScan | Baseline, 12 week | 
| Change of Ceramides in stratum corneum | ultra-performance liquid chromatography system etc. | Baseline, 12 week | 
| Change of Natural moisturizing factor in stratum corneum | Ultra-performance liquid chromatography system etc. | Baseline, 12 week | 
| Change from baseline in TEWL | Transepidermal water loss measured by vapometer | Baseline, 12 week |