Clinical trial NCT06847035: Efficacy Study of Oral Collagen Peptide on Skin Condition Improvement
Official title: Efficacy Study of Oral Collagen Peptide on Skin Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Lead sponsor: Shanghai Meifute Biotechnology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Skin firmness
timeFrame: 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)
measure: Skin thickness
timeFrame: 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)
measure: Skin density
timeFrame: 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:
measure: Skin hydration
timeFrame: 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)
measure: Skin barrier
timeFrame: 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)
measure: Facial image
timeFrame: 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)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Fumei Dermatology Clinic
state: Shanghai
Study officials:
References: