Efficacy and Safety of AP Collagen Peptide on the Skin

Not Applicable

Completed

• Conditions: Dry Skin
• Interventions: Dietary Supplement: AP collagen peptide; Dietary Supplement: Placebo

• Registration Number: NCT05059197
• Lead Sponsor: Amorepacific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-15
• Status Verified: 2021-09
• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-28
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-12
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AP collagen peptide	AP collagen peptide	Each subject takes one active bottle per day for 12 weeks. Each bottle contains AP collagen 1000 mg
Placebo	Placebo	Each subject takes one active bottle per day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline in epidermal hydration	Baseline, 12 week	skin hydration measured by MoistureMeter-D compact

Secondary Outcome Measures

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

Trial Locations

Locations (1)

P&K Skin Research Center; 🇰🇷 Seoul, Korea, Republic of