The purpose of the study is to investigate the impact of the injection of dermal filler on the quality of the skin dermal extracellular matrix in persons between the ages of 30-50 years. The quality of the dermal extracellular matrix will be assessed following injection of dermal filler compared to injection of saline vehicle.
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.
Single group
Restylane-L
DeviceUsing 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
Vehicle
DeviceTwo 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.
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.
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University of Michigan
Lead sponsor
Galderma R&D
Collaborator
