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

Last updated: July 2, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Skin Aging

Treatment

Restylane-L

Vehicle

Clinical Study ID

NCT06195605
HUM00230920
  • Ages 30-50
  • All Genders

Study Summary

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 Criteria

Inclusion

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

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 cardiacconduction, severely impaired hepatic function or severe renal dysfunction.

  • Individuals with active inflammation or infection of the skin, including activeherpes infection.

  • Have a significant medical history or concurrent condition which the investigator(s)feel is not safe for study participation, including history of frequent herpesinfections, and subjects planning to be exposed to excessive sun, Ultraviolet lampsand 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, orinhibitors 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 makeparticipation unsafe for you

  • Have a history of connective tissue diseases, such as:

  • rheumatoid arthritis

  • scleroderma

  • polymyositis/dermatomyositis

  • systemic lupus erythematosus (SLE)

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Restylane-L
Phase:
Study Start date:
May 09, 2024
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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