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

Conditions

• Photoaging

Eligibility Criteria

Sex

ALL

Age

30 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

May 9, 2024

Status verified

Jul 2025

Primary completion

Nov 30, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Photodamaged skin

Primary Outcome Measure

Extracellular Matrix (ECM) deposition as measured using histological stain(s) of skin [ Time Frame: Approximately 4 weeks ]

Central Contacts

• Diane Fiolek
  734-763-1469
  [email protected]

Locations (1)

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