Recruiting NCT06195605
Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Restylane-L, Vehicle.
- Who it may be relevant to
- Registry conditions: Photoaging. Basic parameters: 30 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 - 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.
Primary outcome measures
- Extracellular Matrix (ECM) deposition as measured using histological stain(s) of skin [Time frame: Approximately 4 weeks]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT06195605 · HUM00230920