Actively Recruiting
Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin
Led by University of Michigan · Updated on 2025-07-08
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
G
Galderma R&D
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of injecting dermal filler on the quality of the skin's dermal extracellular matrix in adults aged 30 to 50 years. The study compares the changes in skin matrix quality after injections of a cross-linked hyaluronic acid filler called Restylane-L to injections of a saline vehicle. The goal is to understand how age influences the skin's response to these injections in the context of photoaging. Participants will receive two injections of Restylane-L, each 0.5 cc, into small areas of the mid-dermis on one forearm. Additionally, they will receive two injections of a saline vehicle in the same manner and forearm. The locations of injections will be carefully tracked using a plastic template related to skin landmarks. This procedure allows comparison between the filler and vehicle effects on the skin. During the study, participants will be monitored approximately 4 weeks after injection to measure extracellular matrix deposition using histological staining of skin samples. The study requires participants to be generally healthy and able to follow the protocol. Safety will be monitored by excluding those with conditions or histories that could increase risk, such as allergies, infections, or immune suppression. The total study duration and follow-up ensure detailed assessment of skin changes after treatment.
CONDITIONS
Brief Title
Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Pregnant, plan to become pregnant during the study, or are nursing a child
- 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 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 might make participation unsafe
- Have a history of connective tissue diseases, such as:
- rheumatoid arthritis
- scleroderma
- polymyositis/dermatomyositis
- systemic lupus erythematosus (SLE)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 4 weeks
Participants receive two injections of cross-linked hyaluronic acid dermal filler (Restylane-L) and two injections of vehicle into the forearm skin to evaluate fibroblast and extracellular matrix responses.
1 visit (in-person) for injections and follow-up assessments
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
D
Diane Fiolek
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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