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

NCT06195605 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-07-08

No results posted yet for this 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.

Conditions

  • Photoaging

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Gary Fisher · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-09
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06195605 on ClinicalTrials.gov