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

Recruiting
30 - 50 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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)

Study details

Photoaging

NCT06195605

University of Michigan

29 May 2024

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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