NCT06502470

Healing Study of Fractional Skin Resurfacing and Tissue Histopathology After Ellacor Treatment

Open Label Study to Explore Healing and Tissue Histopathology Following Ellacor Micro-Coring Procedures in an Abdominoplasty Model

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Cytrellis Biosystems, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to observe the healing of skin after ellacor® treatment at different timepoints, depths and coring densities. The visual comparison of treated areas to untreated control areas will improve understanding of how the ellacor® procedure works to induce skin resurfacing using an abdominoplasty, or tummy tuck surgery, model. The people participating in the study will have already decided that they want to have an abdominoplasty procedure. The main questions this study aims to answer are: How does human skin change after a series of the ellacor® procedures over a 14-day period? Is the ellacor® device safe to use at different treatment time points, depths and densities? The ellacor® procedure will be performed on people who are going to have abdominoplasty surgery. The ellacor® treatment areas will be limited to the skin areas marked for removal during the abdominoplasty. The treated tissue will be sent to a lab for microscopic study after the abdominoplasty procedure is complete. A minimum of 3 people will be treated in the study. The 3 participants will have the ellacor® procedure done at 4 different timepoints before their abdominoplasty surgery: -14 days, -7 days, -3 days and on day 0, just prior to the abdominoplasty procedure. At each treatment timepoint the participants will have 3 areas treated using a depth of 7mm and different skin removal percent settings of 5%, 7% and 8%. The participants will have photos taken of the treatment areas and will be asked about any changes to their health or medications over the 14-day study. Researchers will study the abdominoplasty tissue under a microscope after it has been removed from the participants. They will compare the areas treated by the ellacor® device to an area left untreated, which is the control area. This will reveal, by visual comparison, any changes in the skin tissue between treated and untreated areas, if they occur.

Conditions

• Wrinkle
• Rhytides
• Histopathology

Interventions

Type	Name	Description
DEVICE	ellacor® Micro-Coring procedure	ellacor® Micro-Coring Technology is FDA approved for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV.

Timeline

• Start date: 2024-04-30
• Primary completion: 2024-05-17
• Completion: 2024-05-17
• First posted: 2024-07-16
• Last updated: 2024-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study