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

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.

Study Overview

• Status: Recruiting
• Conditions: Photoaging
• Intervention / Treatment: Device: Restylane-L; Device: Vehicle

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diane Fiolek; Phone Number: 734-763-1469; Email: dianemch@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Diane Fiolek; Phone Number: 734-763-1469; Email: dianemch@med.umich.edu
      • Principal Investigator: Gary Fisher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Photodamaged skin

Device: Restylane-L; Using 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; Device: Vehicle; Two 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately 4 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Galderma R&D
• Investigators: Principal Investigator: Gary Fisher, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: dermal filler; Hyaluronic acid; Extracellular matrix
• Other Study ID Numbers: HUM00230920

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes