Efficacy and Safety of AP Collagen Peptide on the Skin | NCT05059197

Studies
Efficacy and Safety of AP Collagen Peptide on the Skin

NCT05059197

Sponsor

Amorepacific Corporation

Status

Completed

Last Update Posted

Nov 11, 2021Actual

Enrollment

54Actual

Phase

Not Applicable

Conditions

Dry Skin

Interventions

AP collagen peptide
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2020Actual

Primary Completion Date

Sep 30, 2021Actual

Completion Date

Oct 12, 2021Actual

First Submitted Date

Sep 17, 2021

First Submission Date that Met QC Criteria

Sep 17, 2021

First Posted Date

Sep 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2021

Last Update Posted Date

Nov 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AP collagen peptide	Experimental	Each subject takes one active bottle per day for 12 weeks. Each bottle contains AP collagen 1000 mg	Dietary Supplement: AP collagen peptide
Placebo	Placebo Comparator	Each subject takes one active bottle per day for 12 weeks.	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AP collagen peptide	Dietary Supplement	Health functional food	AP collagen peptide

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided