Efficacy and Safety of AP Collagen Peptide on the Skin

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Skin
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: AP collagen peptide

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07236
    • P&K Skin Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AP collagen peptide; Each subject takes one active bottle per day for 12 weeks. Each bottle contains AP collagen 1000 mg	Dietary supplement: AP collagen peptide; Health functional food
PLACEBO_COMPARATOR: Placebo; Each subject takes one active bottle per day for 12 weeks.	Dietary supplement: Placebo; placebo

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

Collaborators and Investigators

• Sponsor: Amorepacific Corporation
• Investigators: Principal Investigator: Hae Kwang Lee, PhD, P&K Skin Research Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2020
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): October 12, 2021

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (ACTUAL): September 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PNK-20D21-FF1R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No