Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin

Launched by UNIVERSITY OF MICHIGAN · Dec 22, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a specific type of skin filler, made from cross-linked hyaluronic acid, affects the quality of the skin in people aged 30 to 50 who are experiencing signs of aging due to sun exposure. Researchers want to see if the filler improves the skin's supporting structure, called the dermal extracellular matrix, compared to a placebo (a harmless saline solution).

To participate, you need to be generally healthy, understand the study, and be willing to follow its requirements. Unfortunately, some people can't join, such as those who are pregnant, have certain skin conditions or allergies, have serious health issues, or are taking specific medications that affect their immune system. If you do participate, you will receive an injection and then be monitored to see how your skin responds over time. This study is a chance to contribute to understanding how age affects skin treatment responses, and it could help improve future cosmetic procedures.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects must understand and sign the informed consent prior to participation
• • Subjects must be in generally good health
• • Subjects must be able and willing to comply with the requirements of the protocol
• Exclusion Criteria:
• • Pregnant, plan to become pregnant during the study, or are nursing a child. Participants will be asked to self-report pregnancy
• • Individuals with bleeding disorders
• • Tend to heal poorly or form very thick scars called keloids
• • Have a lidocaine sensitivity, including those with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
• • Individuals with active inflammation or infection of the skin, including active herpes infection.
• • Have a significant medical history or concurrent condition which the investigator(s) feel is not safe for study participation, including history of frequent herpes infections, and subjects planning to be exposed to excessive sun, Ultraviolet lamps and extreme cold weather during the first week after injection.
• • History of allergies to gram positive bacterial proteins
• • Individuals with who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
• • Have an active inflammation or infection of the skin near the site of injection
• • Are taking any medications that suppress your immune system
• • Have severe allergies to medications or other things that we believe might make participation unsafe for you
• * Have a history of connective tissue diseases, such as:
• • rheumatoid arthritis
• • scleroderma
• • polymyositis/dermatomyositis
• • systemic lupus erythematosus (SLE)