- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05670977
Improved Skin Anti-aging Outcomes Associated With Collagen Fortified Consumption In 30 to 50-Year-old Women
A Randomized, Double Blind, Controlled Study of Improved Skin Anti-aging Outcomes Associated With Collagen Fortified Consumption In 30 to 50-Year-old Women
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China
- Ai'er Hospital
-
Contact:
- Melody Hou
- Phone Number: +8613917849430
- Email: melody.hou@sprimmedical.com
-
Shanghai, Shanghai, China
- SPRIM Central Lab
-
Contact:
- Melody Hou
- Phone Number: +8613917849430
- Email: melody.hou@sprimmedical.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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 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.
Study Plan
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: Study product plus collagen supplement
5g/bag, containing the following ingredients per 5g serving:
|
The participants in this arm will use the assigned product for 2 months, 5g one time, once a day.
|
Placebo Comparator: Study product without collagen supplement
5g/bag, containing the following ingredients per 5g serving:
|
The participants in this arm will use the assigned product for 2 months, 5g one time, once a day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin Elasticity
Time Frame: baseline day 0, day 60
|
The changes of skin elasticity from baseline to day 60 by CK Cutometer MPA580
|
baseline day 0, day 60
|
Skin Moisture
Time Frame: baseline day 0, day 60
|
The changes of skin moisture from baseline to day 60 by Corneometer CM 825
|
baseline day 0, 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
|
Facial Glow
Time Frame: baseline day 0, day 30, day 60
|
The changes of Facial Glow by expert visual assessment
|
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
Investigators
- Principal Investigator: Yun Wang, MD, NO. 9 Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-SM-12-HT-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Skin Laxity
-
Rocky Mountain Biosystems, Inc.CompletedLaxity of SkinUnited States
-
Rocky Mountain Biosystems, Inc.CompletedLaxity of SkinUnited States
-
Merz North America, Inc.Ulthera, IncCompletedMild to Moderate Skin Laxity Under the Chin | Mild to Moderate Skin Laxity on NeckUnited States
-
Apsara Medical CorporationCompleted
-
Ulthera, IncCompletedSkin Laxity of the décolletéUnited States
-
Ulthera, IncUniversity of Texas Southwestern Medical CenterCompletedMild to Moderate Skin Laxity on Cheek | Mild to Moderate Skin Laxity on Upper Neck | Mild to Moderate Subcutaneous Fat on Cheek | Mild to Moderate Subcutaneous Fat on Upper Neck
-
Derming SRLCompletedFace Skin LaxityItaly
-
Nashville Centre for Laser and Facial SurgeryBausch HealthUnknownFacial Skin Laxity
-
Ulthera, IncCompletedFacial Skin LaxityUnited States
-
Endo PharmaceuticalsCompletedLaxity; Skin | Cellulite | Edematous Fibrosclerotic PanniculopathyUnited States
Clinical Trials on Study product plus collagen supplement
-
Abbott NutritionWithdrawn
-
Abbott NutritionCompleted
-
Liverpool John Moores UniversityCompletedTendon Stiffness With AgeUnited Kingdom
-
Bionos Biotech S.L.Completed
-
Chulalongkorn UniversityNot yet recruiting
-
University of TorontoActive, not recruiting
-
Arthur van ZantenRousselot BVBA; Intensive Care Research Foundation, Gelderse Vallei HospitalRecruitingCritical Illness | Intensive Care Unit Acquired WeaknessNetherlands
-
Covalon Technologies Inc.ALS Beauty and Personal CareCompleted
-
Shenzhen Precision Health Food Technology Co. Ltd...Active, not recruiting
-
University Hospital, GenevaDanone ResearchCompletedAnorexia NervosaSwitzerland