Efficacy and Safety of AP Collagen Peptide on the Skin

NCT05059197 | Completed

• 1 other identifier: PNK-20D21-FF1R
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Skin

Outcome Measures

Primary Outcomes (1)

• Change from baseline in epidermal hydration

  skin hydration measured by MoistureMeter-D compact

  Baseline, 12 week

Secondary Outcomes (6)

• Change from baseline in skin roughness (texture)

  Baseline, 12 week

• Change from baseline in skin gloss

  Baseline, 12 week

• Change from baseline in stratum corneum condition

  Baseline, 12 week

• Change of Ceramides in stratum corneum

  Baseline, 12 week

• Change of Natural moisturizing factor in stratum corneum

  Baseline, 12 week

Study Arms (2)

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

AP collagen peptide DIETARY_SUPPLEMENT

Health functional food

AP collagen peptide

Placebo DIETARY_SUPPLEMENT

placebo

Placebo

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amorepacific Corporation: lead

Study Sites (1)

P&K Skin Research Center

Seoul, 07236, South Korea

Location

Study Officials

• Hae Kwang Lee, PhD

  P&K Skin Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: December 15, 2020
• Primary Completion: September 30, 2021
• Study Completion: October 12, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)