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Improved Skin Anti-aging Outcomes Associated With Collagen Fortified Consumption In 30 to 50-Year-old Women

Primary Purpose

Skin Laxity, Skin Lines

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Study product plus collagen supplement
Study product without collagen supplement
Sponsored by
Guangdong HuaPeptides Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Skin Laxity focused on measuring Collagen, skin anti-aging, skin moisture, skin elasticity

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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 bagcer, including but not limited to any type of skin bagcer (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.

Sites / Locations

  • Ai'er Hospital
  • SPRIM Central Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Study product plus collagen supplement

Study product without collagen supplement

Arm Description

5g/bag, containing the following ingredients per 5g serving: Collagen tripeptide 1500 mg Elastin peptide 150 mg

5g/bag, containing the following ingredients per 5g serving: Peach juice 8 mg Erythritol 10 mg

Outcomes

Primary Outcome Measures

Skin Elasticity
The changes of skin elasticity from baseline to day 60 by CK Cutometer MPA580
Skin Moisture
The changes of skin moisture from baseline to day 60 by Corneometer CM 825

Secondary Outcome Measures

Skin Barrier
The changes of skin barrier in terms of TEWL (Trans Epidermal Water Loss) by Aquaflux F200
Lines/Wrinkles
The changes of the lines/wrinkles on the face by Miravex Antera 3D imaging system
Facial Glow
The changes of Facial Glow by expert visual assessment
Skin Diagnosis
The skin diagnosis (4 modes and 2 side views) with VISIA CR Facial Imaging System

Full Information

First Posted
January 2, 2023
Last Updated
April 11, 2023
Sponsor
Guangdong HuaPeptides Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05670977
Brief Title
Improved Skin Anti-aging Outcomes Associated With Collagen Fortified Consumption In 30 to 50-Year-old Women
Official Title
A Randomized, Double Blind, Controlled Study of Improved Skin Anti-aging Outcomes Associated With Collagen Fortified Consumption In 30 to 50-Year-old Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
March 12, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong HuaPeptides Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to study the efficacy of collagen supplement on the moisture content and elasticity. 70 participants of 30-50 years old women will be enrolled from two study sites and randomly assigned to use two products (study product plus collagen supplement and placebo product without collagen supplement) for 2 months. Researchers will compare the two groups to validate the assumption that there is significant improvement on skin anti-aging effect for participants using study product plus collagen supplement.
Detailed Description
This study is two arms, randomized, double-blind controlled trial. There will be two study sites and 35 eligible participants at each study site will be enrolled with the expectation of having 30 participants completed per study group. Particants will be randomly allocated to use one of the two study products defined in the trial protocol for two months. Up to three study visits will be made by the participant over a 2-month period. All relevant data will be captured and recorded into CTMS (Clinical Trial Management System). The data will be analyzed and reported after the completion of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity, Skin Lines
Keywords
Collagen, skin anti-aging, skin moisture, skin elasticity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study product plus collagen supplement
Arm Type
Active Comparator
Arm Description
5g/bag, containing the following ingredients per 5g serving: Collagen tripeptide 1500 mg Elastin peptide 150 mg
Arm Title
Study product without collagen supplement
Arm Type
Placebo Comparator
Arm Description
5g/bag, containing the following ingredients per 5g serving: Peach juice 8 mg Erythritol 10 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Study product plus collagen supplement
Intervention Description
The participants in this arm will use the assigned product for 2 months, 5g one time, once a day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Study product without collagen supplement
Intervention Description
The participants in this arm will use the assigned product for 2 months, 5g one time, once a day.
Primary Outcome Measure Information:
Title
Skin Elasticity
Description
The changes of skin elasticity from baseline to day 60 by CK Cutometer MPA580
Time Frame
baseline day 0, day 60
Title
Skin Moisture
Description
The changes of skin moisture from baseline to day 60 by Corneometer CM 825
Time Frame
baseline day 0, day 60
Secondary Outcome Measure Information:
Title
Skin Barrier
Description
The changes of skin barrier in terms of TEWL (Trans Epidermal Water Loss) by Aquaflux F200
Time Frame
baseline day 0, day 30, day 60
Title
Lines/Wrinkles
Description
The changes of the lines/wrinkles on the face by Miravex Antera 3D imaging system
Time Frame
baseline day 0, day 30, day 60
Title
Facial Glow
Description
The changes of Facial Glow by expert visual assessment
Time Frame
baseline day 0, day 30, day 60
Title
Skin Diagnosis
Description
The skin diagnosis (4 modes and 2 side views) with VISIA CR Facial Imaging System
Time Frame
baseline day 0, day 30, day 60

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants must be women of 30-50 years old
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 bagcer, including but not limited to any type of skin bagcer (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Wang, MD
Organizational Affiliation
NO. 9 Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ai'er Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
SPRIM Central Lab
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23949208
Citation
Proksch E, Segger D, Degwert J, Schunck M, Zague V, Oesser S. Oral supplementation of specific collagen peptides has beneficial effects on human skin physiology: a double-blind, placebo-controlled study. Skin Pharmacol Physiol. 2014;27(1):47-55. doi: 10.1159/000351376. Epub 2013 Aug 14.
Results Reference
background
PubMed Identifier
24401291
Citation
Proksch E, Schunck M, Zague V, Segger D, Degwert J, Oesser S. Oral intake of specific bioactive collagen peptides reduces skin wrinkles and increases dermal matrix synthesis. Skin Pharmacol Physiol. 2014;27(3):113-9. doi: 10.1159/000355523. Epub 2013 Dec 24.
Results Reference
background
PubMed Identifier
34958693
Citation
Shariff R, Du Y, Dutta M, Kumar S 5th, Thimmaiah S, Doraiswamy C, Kumari A, Kale V, Nair N, Zhang S, Joshi M, Santhanam U, Qiang Q, Damodaran A. Superior even skin tone and anti-ageing benefit of a combination of 4-hexylresorcinol and niacinamide. Int J Cosmet Sci. 2022 Feb;44(1):103-117. doi: 10.1111/ics.12759. Epub 2022 Feb 1.
Results Reference
background
PubMed Identifier
34313461
Citation
Wang L, Xu YN, Chu CC, Jing Z, Chen Y, Zhang J, Pu M, Mi T, Du Y, Liang Z, Doraiswamy C, Zeng T, Wu J, Chen L. Facial Skin Microbiota-Mediated Host Response to Pollution Stress Revealed by Microbiome Networks of Individual. mSystems. 2021 Aug 31;6(4):e0031921. doi: 10.1128/mSystems.00319-21. Epub 2021 Jul 27.
Results Reference
background
PubMed Identifier
35785442
Citation
Du Y, Doraiswamy C, Mao J, Zhang Q, Liang Y, Du Z, Vasantharaghavan R, Joshi MK. Facial skin characteristics and concerns in Indonesia: A cross-sectional observational study. Skin Res Technol. 2022 Sep;28(5):719-728. doi: 10.1111/srt.13189. Epub 2022 Jul 4.
Results Reference
background

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Improved Skin Anti-aging Outcomes Associated With Collagen Fortified Consumption In 30 to 50-Year-old Women

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