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

Not Applicable

Recruiting

• Conditions: Photoaging
• Interventions: Device: Restylane-L; Device: Vehicle

• Registration Number: NCT06195605
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2023-12-22
• Study First Posted: 2024-01-08
• Status Verified: 2024-05
• Study Start: 2024-05-09
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-24
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Photodamaged skin	Vehicle	-
Photodamaged skin	Restylane-L	-

Primary Outcome Measures

Name	Time	Method
Extracellular Matrix (ECM) deposition as measured using histological stain(s) of skin	Approximately 4 weeks	Reported as a semi-quantitative grade. The grading scale is 1-4. The higher the number to increased ECM deposition.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States