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

Skin Laxity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05670977
• Other study ID #: 22-SM-12-HT-001
• Status: Completed
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: Guangdong HuaPeptides Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 31, 2023
• Est. primary completion date: March 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

Dietary Supplement:
• Study product plus collagen supplement
The participants in this arm will use the assigned product for 2 months, 5g one time, once a day.
• Study product without collagen supplement
The participants in this arm will use the assigned product for 2 months, 5g one time, once a day.

Locations

Country	Name	City	State
China	Ai'er Hospital	Shanghai	Shanghai
China	SPRIM Central Lab	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong HuaPeptides Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin Elasticity	The changes of skin elasticity from baseline to day 60 by CK Cutometer MPA580	baseline day 0, day 60
Primary	Skin Moisture	The changes of skin moisture from baseline to day 60 by Corneometer CM 825	baseline day 0, day 60
Secondary	Skin Barrier	The changes of skin barrier in terms of TEWL (Trans Epidermal Water Loss) by Aquaflux F200	baseline day 0, day 30, day 60
Secondary	Lines/Wrinkles	The changes of the lines/wrinkles on the face by Miravex Antera 3D imaging system	baseline day 0, day 30, day 60
Secondary	Facial Glow	The changes of Facial Glow by expert visual assessment	baseline day 0, day 30, day 60
Secondary	Skin Diagnosis	The skin diagnosis (4 modes and 2 side views) with VISIA CR Facial Imaging System	baseline day 0, day 30, day 60