Investigating how age affects skin responses to hyaluronic acid filler
Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin
This study is testing how age affects the skin's reaction to a popular filler treatment in people aged 30 to 50 to see which age group benefits the most.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 30 Years to 50 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06195605 on ClinicalTrials.gov |
What this trial studies
This study examines the effects of injecting a dermal filler, specifically Restylane-L, on the quality of the skin's extracellular matrix in individuals aged 30 to 50. Participants will receive either the dermal filler or a saline vehicle, allowing researchers to compare the outcomes. The study aims to understand how age influences skin response to this treatment, which could provide insights into optimal cosmetic interventions for different age groups.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals aged 30 to 50 who are seeking cosmetic improvement for photoaging.
Not a fit: Patients who are pregnant, have bleeding disorders, or active skin infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of dermal fillers in improving skin quality for patients experiencing photoaging.
How similar studies have performed: While there have been studies on dermal fillers, this specific investigation into age dependence and extracellular matrix responses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Gary Fisher — University of Michigan
- Study coordinator: Diane Fiolek
- Email: dianemch@med.umich.edu
- Phone: 734-763-1469
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.