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

NCT05670977 | Completed

• 1 other identifier: 22-SM-12-HT-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Skin Laxity; Skin Lines

Keywords

Collagen; skin anti-aging; skin moisture; skin elasticity

Outcome Measures

Primary Outcomes (2)

• Skin Elasticity

  The changes of skin elasticity from baseline to day 60 by CK Cutometer MPA580

  baseline day 0, day 60

• Skin Moisture

  The changes of skin moisture from baseline to day 60 by Corneometer CM 825

  baseline day 0, day 60

Secondary Outcomes (4)

• Skin Barrier

  baseline day 0, day 30, day 60

• Lines/Wrinkles

  baseline day 0, day 30, day 60

• Facial Glow

  baseline day 0, day 30, day 60

• Skin Diagnosis

  baseline day 0, day 30, day 60

Study Arms (2)

Study product plus collagen supplement

ACTIVE COMPARATOR

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

Dietary Supplement: Study product plus collagen supplement

Study product without collagen supplement

PLACEBO COMPARATOR

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

Dietary Supplement: Study product without collagen supplement

Interventions

Study product plus collagen supplement DIETARY_SUPPLEMENT

The participants in this arm will use the assigned product for 2 months, 5g one time, once a day.

Study product plus collagen supplement

Study product without collagen supplement DIETARY_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

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: Participants must be women of 30-50 years old
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong HuaPeptides Biotechnology Co., Ltd.: lead

Study Sites (2)

Ai'er Hospital

Shanghai, Shanghai Municipality, China

Location

SPRIM Central Lab

Shanghai, Shanghai Municipality, China

Location

Related Publications (5)

• 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.

  PMID: 23949208 BACKGROUND

• 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.

  PMID: 24401291 BACKGROUND

• 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.

  PMID: 34958693 BACKGROUND

• 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.

  PMID: 34313461 BACKGROUND

• 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.

  PMID: 35785442 BACKGROUND

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Yun Wang, MD

  NO. 9 Hospital affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 4, 2023
• Study Start: January 16, 2023
• Primary Completion: March 12, 2023
• Study Completion: March 31, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)