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OpenTrials
Completed

NCT Number: NCT05059197

Efficacy and Safety of AP Collagen Peptide on the Skin

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.

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Key information

Conditions

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

P&K Skin Research Center

Seoul, 07236, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AP collagen peptide

Dietary Supplement

Health functional food

Placebo

Dietary Supplement

placebo

Primary outcomes

  1. Change from baseline in epidermal hydration

    Time frame: Baseline, 12 week

    skin hydration measured by MoistureMeter-D compact

Secondary outcomes

  1. Change from baseline in skin roughness (texture)

    Time frame: Baseline, 12 week

    skin roughness measured by PRIMOS

  2. Change from baseline in skin gloss

    Time frame: Baseline, 12 week

    skin roughness measured by Skinglossmeter

  3. Change from baseline in stratum corneum condition

    Time frame: Baseline, 12 week

    stripped using 10 tape strips (D-Squame) and measured by VisioScan

  4. Change of Ceramides in stratum corneum

    Time frame: Baseline, 12 week

    ultra-performance liquid chromatography system etc.

  5. Change of Natural moisturizing factor in stratum corneum

    Time frame: Baseline, 12 week

    Ultra-performance liquid chromatography system etc.

  6. Change from baseline in TEWL

    Time frame: Baseline, 12 week

    Transepidermal water loss measured by vapometer

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2021
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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