Clinical trial NCT05059197: Efficacy and Safety of AP Collagen Peptide on the Skin
Official title: Evaluation of Skin Health Improvement and Safety in AP Collagen Peptide: Randomized, Double-blind, Placebo-controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Skin
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2021-09-28
Enrollment: 54
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change from baseline in epidermal hydration
timeFrame: Baseline, 12 week
Secondary outcomes:
measure: Change from baseline in skin roughness (texture)
timeFrame: Baseline, 12 week
measure: Change from baseline in skin gloss
timeFrame: Baseline, 12 week
measure: Change from baseline in stratum corneum condition
timeFrame: Baseline, 12 week
measure: Change of Ceramides in stratum corneum
timeFrame: Baseline, 12 week
measure: Change of Natural moisturizing factor in stratum corneum
timeFrame: Baseline, 12 week
measure: Change from baseline in TEWL
timeFrame: Baseline, 12 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: P&K Skin Research Center
Study officials:
affiliation: P&K Skin Research Center
name: Hae Kwang Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: