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Completed

NCT Number: NCT06847035

Efficacy Study of Oral Collagen Peptide on Skin Condition Improvement

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

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Key information

Conditions

Age range

35 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Fumei Dermatology Clinic

Shanghai, Shanghai Municipality, 021, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Active Comparator

Dietary Supplement

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

Placebo Comparator

Dietary Supplement

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

Other names: placebo solid beverage

Primary outcomes

  1. Skin firmness

    Time frame: 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)

    The changes of skin firmness parameter tested by Cutometer MPA580

  2. Skin thickness

    Time frame: 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)

    The changes of skin thickness (μm) tested by Ultrascan UC 22

  3. Skin density

    Time frame: 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)

    The changes of skin density tested by Ultrascan UC 22

Secondary outcomes

  1. Skin hydration

    Time frame: 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)

    The changes of skin hydration tested by Corneometer CM825

  2. Skin barrier

    Time frame: 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)

    The changes of Trans Epidermal Water Loss (skin barrier parameter) tested by Tewameter TM300

  3. Facial image

    Time frame: 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)

    Photo documents of left, right and frontal facial views

Sponsors and collaborators

Lead sponsor

Shanghai Meifute Biotechnology Co., Ltd

Industry

Registry information

Official study title

Efficacy Study of Oral Collagen Peptide on Skin Conditions

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2025
Registry last updated
Feb 28, 2025

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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