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Universiteit van MichiganInvestigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin
Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin
- HUM00230920
Hyaluronic acid
dermal filler
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelPhotodamaged skin | Restylane-l Using a small gauge metal hub needle, two injections of CL-HA dermal filler (Restylane-L) will be performed, each into a small area (approximately 2 x 2 cm) of the mid-dermis of a forearm of a subject. Each injection will be 0.5 cc in volume, and will be approximately 2 cm apart from each other Voertuig Two injections of vehicle will be performed in the same manner as Restylane-L and in the same forearm, totaling 4 injections. A plastic template will be used to track the location of the injections, relative to landmarks on the skin. |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Extracellular Matrix (ECM) deposition as measured using histological stain(s) of skin | Reported as a semi-quantitative grade. The grading scale is 1-4. The higher the number to increased ECM deposition. | Approximately 4 weeks |
- 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
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)
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