Efficacy and Safety of AP Collagen Peptide on the Skin

Sponsor

Amorepacific Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT05059197

Collaborator

(none)

Enrollment

Location

Arms

9.9

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Skin	Dietary Supplement: AP collagen peptide Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 15, 2020

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Oct 12, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline in epidermal hydration [Baseline, 12 week]
skin hydration measured by MoistureMeter-D compact

Secondary Outcome Measures

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 from baseline in stratum corneum condition [Baseline, 12 week]
stripped using 10 tape strips (D-Squame) and measured by VisioScan
Change of Ceramides in stratum corneum [Baseline, 12 week]
ultra-performance liquid chromatography system etc.
Change of Natural moisturizing factor 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	P&K Skin Research Center	Seoul		Korea, Republic of	07236

Sponsors and Collaborators

Amorepacific Corporation

Investigators

Principal Investigator: Hae Kwang Lee, PhD, P&K Skin Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amorepacific Corporation

ClinicalTrials.gov Identifier:

NCT05059197

Other Study ID Numbers:

PNK-20D21-FF1R

First Posted:

Sep 28, 2021

Last Update Posted:

Nov 11, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 11, 2021