Clinical trial NCT05682092: Study of Collagen Efficacy on Skin Anti-aging in 30 to 50-Year-Old Women
Official title: A Randomized Double-blind Controlled Study of Collagen Efficacy on Skin Anti-aging in 30 to 50-Year-Old Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Skin Fold
Keywords: Collagen
skin hydration
skin elasticity
anti-aging
Lead sponsor: Shenzhen Precision Health Food Technology Co. Ltd.,
Sponsor class: OTHER_GOV
First posted: 2023-01-12
Enrollment: 70
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This is a two arms, randomized, double-blind controlled trial. Study product plus collagen supplement and placebo product but without collagen will be randomly assigned to 70 eligible participants who will be enrolled at two study sites in Shanghai. Participants need to use the assigned product one bottle (25ml) each time, twice a day and visit the study site for three times (baseline day, day 30 and day 60) during the 2-month study. For each visit, the primary outcomes (skin hydration and skin elasticity) and secondary outcomes (skin barrier, lines/wrinkles, and facial glow,etc.) will be measured with professional equiment and imaging system and recorded to data management system. At the end of the study, the study data will exported and analyzed to validate the assumption that the collagen could improve skin moisture content and elasticity in middle-aged women of 30-50 years old.

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 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.

Primary outcomes:
measure: Skin Elasticity
timeFrame: baseline day 0, day 30, day 60
measure: Skin Moisture
timeFrame: baseline day 0, day 30, day 60
Secondary outcomes:
measure: Skin Barrier
timeFrame: baseline day 0, day 30, day 60
measure: Lines/Wrinkles
timeFrame: baseline day 0, day 30, day 60
measure: Skin Diagnosis
timeFrame: baseline day 0, day 30, day 60
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ai'er Hospital
state: Shanghai
city: Shanghai
country: China
facility: SPRIM Central Lab
state: Shanghai
Study officials:
affiliation: NO. 9 Hospital affiliated to Shanghai Jiao Tong University School of Medicine
name: Yun Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
citation: 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.
citation: 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.