Efficacy Study of Oral Collagen Peptide on Skin Condition Improvement

Efficacy Study of Oral Collagen Peptide on Skin Conditions

To assess if oral intake of collagen peptide can improve skin conditions such as skin thickness, density and firmness.

Study Overview

• Status: Completed
• Conditions: Skin Aging
• Intervention / Treatment: Dietary supplement: Active Comparator; Dietary supplement: Placebo Comparator

Detailed Description

This is an one site, randomized, double-blind controlled clinical trial to assess the oral supplement of LISAVEI collagen peptide solid beverage on skin ageing improvement. Study product with collagen peptide and placebo product without collagen were randomly assigned to 90 eligible participants enrolled according to the inclusion and exclusion criteria. They took the assigned product once daily dissolved in 100 ml warm water for 12 weeks with 4-week regression phase(without intake of the test products), and visit the study site in Shanghai for four times(before starting the treatment, after 8 and 12 weeks, and 4 weeks after the last intake). Skin measurements including skin firmness, skin density, skin hydration and skin barrier were carried out at each visit with professional equipment and imaging system. Data were analyzed to validate if the administration of the test collagen peptide solid beverage will improve skin aging parameters such as firmness, thickness, density, hydration and skin barrier compared to placebo. The lasting effect was also observed by comparing between the two groups after 4-week regression time.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 021
      • Shanghai Fumei Dermatology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Healthy female adults aged between 35-55 years old
2. With fine wrinkles and skin laxity
3. Personal informed consents to participate in the study
4. Agree to keep their daily skincare routine unchanged for the duration of the study
5. Maintain good sun protection habits

5. Agree to refrain from wearing make-up on the face on the each study visit

Exclusion Criteria

1. Female who is pregnant or nursing or planning to become pregnant during the course of the study
2. Individuals who are in the perimenopausal stage.
3. BMI<18.5 or BMI >27.9
4. Individuals suffering from chronic systemic diseases such as cardiovascular, cerebrovascular, liver, and kidney diseases.
5. Individuals who have diabetes.
6. Individuals suffering from skin conditions such as psoriasis, eczema, atopic dermatitis, and severe acne.
7. Individuals with depression or sleep disorders, those who smoke, and those who abuse alcohol.
8. Individuals who are using hormonal drugs, medications for obesity, absorption inhibitors, antidepressants, or appetite suppressants.
9. Individuals who have used hormones or anti-inflammatory drugs on their face and upper arms within the past two months.
10. Individuals who received facial laser therapy, chemical peeling or UV overexposure in the past 3 months
11. Individuals who can not avoid prolonged exposure to sunlight.
12. Individuals who are currently participating in other clinical studies or trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator; collagen peptide solid beverage	Dietary supplement: Active Comparator; LISAVEI collagen peptide solid beverage ( contain 5 g collagen peptide)，once daily for 12 weeks
Placebo Comparator: Placebo Comaprator; placebo solid beverage	Dietary supplement: Placebo Comparator; placebo solid beverage (Maltodextrin with edible flavor)，once daily for 12 weeks; Other Names: placebo solid beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin firmness	The changes of skin firmness parameter tested by Cutometer MPA580	before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
Skin thickness	The changes of skin thickness （μm） tested by Ultrascan UC 22	before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
Skin density	The changes of skin density tested by Ultrascan UC 22	before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin hydration	The changes of skin hydration tested by Corneometer CM825	before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
Skin barrier	The changes of Trans Epidermal Water Loss (skin barrier parameter) tested by Tewameter TM300	before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
Facial image	Photo documents of left, right and frontal facial views	before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)

Collaborators and Investigators

• Sponsor: Shanghai Meifute Biotechnology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Actual): November 19, 2024
• Study Completion (Actual): November 19, 2024

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: YKEC-2024-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No