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

NCT06195605 | Recruiting FDA Device

• 1 other identifier: HUM00230920
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Photoaging

Keywords

Extracellular matrix; Hyaluronic acid; dermal filler

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Photodamaged skin

EXPERIMENTAL

Device: Restylane-L; Device: Vehicle

Interventions

Restylane-L DEVICE

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

Photodamaged skin

Vehicle DEVICE

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.

Photodamaged skin

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Galderma R&D: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Interventions

Pharmaceutical Vehicles

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Drug Delivery Systems; Drug Therapy; Therapeutics

Study Officials

• Gary Fisher

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane Fiolek

CONTACT

734-763-1469; dianemch@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: May 9, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)