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

NCT ID: NCT06195605

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-09
• Study Completion Date: 2026-11-30

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.

Conditions

Photoaging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Photodamaged skin

Group Type: EXPERIMENTAL

Restylane-L

Intervention Type: 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

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Gary Fisher

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary Fisher

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Diane Fiolek

Role: CONTACT

dianemch@med.umich.edu

734-763-1469

Facility Contacts

Diane Fiolek

Role: primary

dianemch@med.umich.edu

734-763-1469

Other Identifiers

HUM00230920

Identifier Type: -

Identifier Source: org_study_id