Skin Laxity Clinical Trial
Official title:
A Randomized Double-blind Controlled Study of Collagen Efficacy on Skin Anti-aging in 30 to 50-Year-Old Women
Verified date | April 2023 |
Source | Shenzhen Precision Health Food Technology Co. Ltd., |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 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. |
Country | Name | City | State |
---|---|---|---|
China | Ai'er Hospital | Shanghai | Shanghai |
China | SPRIM Central Lab | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shenzhen Precision Health Food Technology Co. Ltd., |
China,
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. — View 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. — 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
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Skin Elasticity | The changes of skin elasticity by CK Cutometer MPA580 | baseline day 0, day 30, day 60 | |
Primary | Skin Moisture | The changes of skin moisture by Corneometer CM 825 | baseline day 0, day 30, 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 | Skin Diagnosis | The skin diagnosis (4 modes and 2 side views) with VISIA CR Facial Imaging System | baseline day 0, day 30, day 60 |
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