Study of Collagen Efficacy on Skin Anti-aging in 30 to 50-Year-Old Women

Not Applicable

Completed

• Conditions: Skin Laxity; Skin Fold
• Interventions: Dietary Supplement: WonderLab Collagen Tripeptide Drink; Dietary Supplement: Ordinary Drink

• Registration Number: NCT05682092
• Lead Sponsor: Shenzhen Precision Health Food Technology Co. Ltd.,

Brief Summary

This goal of this clinical trial is to study the efficacy of collagen supplement on skin moisture and elasticity in middle-aged women of 30-50 years old.

Participants will be assigned two products with and without collagen supplement and use for 2 months, twice a day.

Researchers will compare the two groups whether there are siginificant improvement of skin moisture and elasticity for participants via skin measurement and anaysis system.

Detailed Description

This is a two arms, randomized, double-blind controlled trial. Study product plus collagen supplement and placebo product but without collagen will be randomly assigned to 70 eligible participants who will be enrolled at two study sites in Shanghai. Participants need to use the assigned product one bottle (25ml) each time, twice a day and visit the study site for three times (baseline day, day 30 and day 60) during the 2-month study. For each visit, the primary outcomes (skin hydration and skin elasticity) and secondary outcomes (skin barrier, lines/wrinkles, and facial glow,etc.) will be measured with professional equiment and imaging system and recorded to data management system. At the end of the study, the study data will exported and analyzed to validate the assumption that the collagen could improve skin moisture content and elasticity in middle-aged women of 30-50 years old.

Study Timeline

• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-12
• Study Start: 2023-01-16
• Primary Completion: 2023-03-12
• Study Completion: 2023-03-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Chinese females, age between 30-50;
• Be in general good health;
• Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate;
• Have mild to moderate darker skin tone 3 on Unilever visual scale of 1~9;
• Have mild pigmentation level 2 on Unilever visual scale of 0~9;
• Have visual grading score on crow's feet 3 on Unilever visual scale of 0~9;
• Have visual grading score on peri-oral 3 on Unilever visual scale of 0~9;
• Have visual grading score on nasolabial folds 3 on Unilever visual scale of 0~9;
• Tolerate to well-known anti-aging actives;
• Agree to not use any other creams, lotions, moisturizers on the face, other than what is provided for the duration of the study;
• Agree to refrain from wearing make-up (such as foundation, eye shadow, lipstick etc.) or any skin care products on the face on the study visits;
• Agree to avoid washing the treatment site area for two hours following product application and agree to avoid washing appliances (i.e., sponge, wash cloth, loofah, etc.).

Exclusion Criteria

• Have used any skin lightening /anti-aging benefits products at least one month before this study
• Subject having done facial injections and/or aesthetic surgery.
• Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product.
• Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently.
• Have a history of any type of bottlecer, including but not limited to any type of skin bottlecer (squamous or basal cell carcinoma at the treatment site) or history of malignant melanoma at any body site.
• Have a history of skin disease or the presence of a skin condition on the test sites that the Investigator feels would interfere with the study.
• Be taking antihistamines (> 3x/week) or anti-inflammatory (> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrolment.
• Have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, diabetes, pregnancy, lactation.
• Have any cuts/abrasions on the test site at baseline.
• Have had a suspicious skin lesion removed by a dermatologist at any time.
• The subject is an employee of sponsor or the site conducting the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WonderLab Collagen Tripeptide Drink	WonderLab Collagen Tripeptide Drink	25ml/bottle, containing the following ingredients per 25ml serving: * Collagen 6000 mg * Vitamins C 250 mg * Hyaluronic acid 50 mg * Nicotinamide 0.45 mg
Ordinary Drink	Ordinary Drink	25ml/bottle, containing the following ingredients per 25ml serving: * Peach juice 8 mg * Erythritol 10 mg

Primary Outcome Measures

Name	Time	Method
Skin Elasticity	baseline day 0, day 30, day 60	The changes of skin elasticity by CK Cutometer MPA580
Skin Moisture	baseline day 0, day 30, day 60	The changes of skin moisture by Corneometer CM 825

Secondary Outcome Measures

Name	Time	Method
Skin Barrier	baseline day 0, day 30, day 60	The changes of skin barrier in terms of TEWL (Trans Epidermal Water Loss) by Aquaflux F200
Lines/Wrinkles	baseline day 0, day 30, day 60	The changes of the lines/wrinkles on the face by Miravex Antera 3D imaging system
Skin Diagnosis	baseline day 0, day 30, day 60	The skin diagnosis (4 modes and 2 side views) with VISIA CR Facial Imaging System

Trial Locations

Locations (2)

SPRIM Central Lab; 🇨🇳 Shanghai, Shanghai, China

Ai'er Hospital; 🇨🇳 Shanghai, Shanghai, China