NCT06847035

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
Last Updated

February 28, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

February 21, 2025

Last Update Submit

February 25, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Skin hydration

    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

    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

    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)

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

collagen peptide solid beverage

Dietary Supplement: Active Comparator

Placebo Comaprator

PLACEBO COMPARATOR

placebo solid beverage

Dietary Supplement: Placebo Comparator

Interventions

Active ComparatorDIETARY_SUPPLEMENT

LISAVEI collagen peptide solid beverage ( contain 5 g collagen peptide),once daily for 12 weeks

Active Comparator
Placebo ComparatorDIETARY_SUPPLEMENT

placebo solid beverage (Maltodextrin with edible flavor),once daily for 12 weeks

Also known as: placebo solid beverage
Placebo Comaprator

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy female adults aged between 35-55 years old
  • With fine wrinkles and skin laxity
  • Personal informed consents to participate in the study
  • Agree to keep their daily skincare routine unchanged for the duration of the study
  • Maintain good sun protection habits
  • \. Agree to refrain from wearing make-up on the face on the each study visit

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Fumei Dermatology Clinic

Shanghai, Shanghai Municipality, 021, China

Location

Related Publications (1)

  • Wang Y, Zhu W, Luo W, Ma Y, Zhou Y. The Sustained Effects of Bioactive Collagen Peptides on Skin Health: A Randomized, Double-Blind, Placebo-Controlled Clinical Study. J Cosmet Dermatol. 2025 Dec;24(12):e70565. doi: 10.1111/jocd.70565.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2025

First Posted

February 26, 2025

Study Start

July 25, 2024

Primary Completion

November 19, 2024

Study Completion

November 19, 2024

Last Updated

February 28, 2025

Record last verified: 2025-01

Locations