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

Photoaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06195605
• Other study ID #: HUM00230920
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: November 2026

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: Diane Fiolek
• Phone: 734-763-1469
• Email: dianemch[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Photoaging

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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