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

NCT05682092 | Completed

• 1 other identifier: 22-SM-11-WL-002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Skin Laxity; Skin Fold

Keywords

Collagen; skin hydration; skin elasticity; anti-aging

Outcome Measures

Primary Outcomes (2)

• Skin Elasticity

  The changes of skin elasticity by CK Cutometer MPA580

  baseline day 0, day 30, day 60

• Skin Moisture

  The changes of skin moisture by Corneometer CM 825

  baseline day 0, day 30, day 60

Secondary Outcomes (3)

• Skin Barrier

  baseline day 0, day 30, day 60

• Lines/Wrinkles

  baseline day 0, day 30, day 60

• Skin Diagnosis

  baseline day 0, day 30, day 60

Study Arms (2)

WonderLab Collagen Tripeptide Drink

ACTIVE COMPARATOR

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

Ordinary Drink

PLACEBO COMPARATOR

25ml/bottle, containing the following ingredients per 25ml serving: * Peach juice 8 mg * Erythritol 10 mg

Dietary Supplement: Ordinary Drink

Interventions

WonderLab Collagen Tripeptide Drink DIETARY_SUPPLEMENT

the participant in this arm will use the assigned product 25ml one time, twice a day.

WonderLab Collagen Tripeptide Drink

Ordinary Drink DIETARY_SUPPLEMENT

the participant in this arm will use the assigned product 25ml one time, twice a day.

Ordinary Drink

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: the participants must be middle-aged 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 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.

Sponsors & Collaborators

• Shenzhen Precision Health Food Technology 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, 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

• Zague V, de Freitas V, da Costa Rosa M, de Castro GA, Jaeger RG, Machado-Santelli GM. Collagen hydrolysate intake increases skin collagen expression and suppresses matrix metalloproteinase 2 activity. J Med Food. 2011 Jun;14(6):618-24. doi: 10.1089/jmf.2010.0085. Epub 2011 Apr 11.

  PMID: 21480801 BACKGROUND

• 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

• Nouveau-Richard S, Yang Z, Mac-Mary S, Li L, Bastien P, Tardy I, Bouillon C, Humbert P, de Lacharriere O. Skin ageing: a comparison between Chinese and European populations. A pilot study. J Dermatol Sci. 2005 Dec;40(3):187-93. doi: 10.1016/j.jdermsci.2005.06.006. Epub 2005 Sep 8.

  PMID: 16154324 BACKGROUND

• Liang J, Pei X, Zhang Z, Wang N, Wang J, Li Y. The protective effects of long-term oral administration of marine collagen hydrolysate from chum salmon on collagen matrix homeostasis in the chronological aged skin of Sprague-Dawley male rats. J Food Sci. 2010 Oct;75(8):H230-8. doi: 10.1111/j.1750-3841.2010.01782.x. Epub 2010 Sep 24.

  PMID: 21535500 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: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 12, 2023
• Study Start: January 16, 2023
• Primary Completion: March 12, 2023
• Study Completion: March 31, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)