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

January 10, 2023 updated by: Shenzhen Precision Health Food Technology Co. Ltd.,

A Randomized Double-blind Controlled Study of Collagen Efficacy on Skin Anti-aging in 30 to 50-Year-Old Women

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Ai'er Hospital
      • Shanghai, Shanghai, China
        • SPRIM Central Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Dietary supplement: WonderLab Collagen Tripeptide Drink
the participant in this arm will use the assigned product 25ml one time, twice a day.
Placebo Comparator: Ordinary Drink

25ml/bottle, containing the following ingredients per 25ml serving:

  • Peach juice 8 mg
  • Erythritol 10 mg
Dietary supplement: Ordinary Drink
the participant in this arm will use the assigned product 25ml one time, twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Elasticity
Time Frame: baseline day 0, day 30, day 60
The changes of skin elasticity by CK Cutometer MPA580
baseline day 0, day 30, day 60
Skin Moisture
Time Frame: baseline day 0, day 30, day 60
The changes of skin moisture by Corneometer CM 825
baseline day 0, day 30, day 60

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Precision Health Food Technology Co. Ltd.,

Investigators

  • Principal Investigator: Yun Wang, MD, NO. 9 Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 9, 2023

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

December 26, 2022

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-SM-11-WL-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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