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

University of Michigan

Status

Enrolling

Conditions

Photoaging

Treatments

Device: Restylane-L

Device: Vehicle

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06195605

HUM00230920

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

30 to 50 years old

Volunteers

No Healthy Volunteers

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)