Actively Recruiting

Phase Not Applicable
Age: 30Years - 50Years
All Genders
NCT06195605

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

Led by University of Michigan · Updated on 2025-07-08

15

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

Sponsors

U

University of Michigan

Lead Sponsor

G

Galderma R&D

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 30Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Pregnant, plan to become pregnant during the study, or are nursing a child
  • 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 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 might make participation unsafe
  • Have a history of connective tissue diseases such as rheumatoid arthritis, scleroderma, polymyositis/dermatomyositis, or systemic lupus erythematosus (SLE)

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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Research Team

D

Diane Fiolek

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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