Efficacy and Safety of AP Collagen Peptide on the Skin

Dry Skin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05059197
• Other study ID #: PNK-20D21-FF1R
• Status: Completed
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: October 12, 2021

Study information

• Verified date: September 2021
• Source: Amorepacific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 12, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Skin

Intervention

Dietary Supplement:
• AP collagen peptide
Health functional food
• Placebo
placebo

Locations

Country	Name	City	State
Korea, Republic of	P&K Skin Research Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Amorepacific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in epidermal hydration	skin hydration measured by MoistureMeter-D compact	Baseline, 12 week
Secondary	Change from baseline in skin roughness (texture)	skin roughness measured by PRIMOS	Baseline, 12 week
Secondary	Change from baseline in skin gloss	skin roughness measured by Skinglossmeter	Baseline, 12 week
Secondary	Change from baseline in stratum corneum condition	stripped using 10 tape strips (D-Squame) and measured by VisioScan	Baseline, 12 week
Secondary	Change of Ceramides in stratum corneum	ultra-performance liquid chromatography system etc.	Baseline, 12 week
Secondary	Change of Natural moisturizing factor in stratum corneum	Ultra-performance liquid chromatography system etc.	Baseline, 12 week
Secondary	Change from baseline in TEWL	Transepidermal water loss measured by vapometer	Baseline, 12 week