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NCT Number: NCT06195605

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.

Recruiting

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Key information

Conditions

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Diane Fiolek

CONTACT

[email protected]

734-763-1469

Gary Fisher

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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.

Primary outcomes

  1. Extracellular Matrix (ECM) deposition as measured using histological stain(s) of skin

    Time frame: Approximately 4 weeks

    Reported as a semi-quantitative grade. The grading scale is 1-4. The higher the number to increased ECM deposition.

Study contacts

Contact information is provided by the study sponsor or research team.

Diane Fiolek

CONTACT

[email protected]

734-763-1469

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Galderma R&D

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2024
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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