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Safety Evaluation of Skin Removal Percentages and Evaluation of Healing over 14 Days. for Wrinkles

N/A
Waitlist Available
Research Sponsored by Cytrellis Biosystems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up adverse events will be collected from day 0 (the initial ellacor treatment day) through the day of the scheduled abdominoplasty procedure (day 14 for all subjects).
Awards & highlights

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.

Eligible Conditions
  • Wrinkles
  • Histopathology

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~adverse events will be collected from day 0 (the initial ellacor treatment day) through the day of the scheduled abdominoplasty procedure (day 14 for all subjects).
This trial's timeline: 3 weeks for screening, Varies for treatment, and adverse events will be collected from day 0 (the initial ellacor treatment day) through the day of the scheduled abdominoplasty procedure (day 14 for all subjects). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and severity of adverse events
The change in histopathology of abdominoplasty tissue samples after sequential treatments with the ellacor® device at a micro-coring depth of 7mm over a 14-day period as compared to an untreated control area.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Safety Evaluation of Skin Removal Percentages and Evaluation of Healing over 14 Days.Experimental Treatment1 Intervention
Three 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 different skin removal percent settings: 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ellacor® Micro-Coring procedure
2024
N/A
~10

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Who is running the clinical trial?

Cytrellis Biosystems, Inc.Lead Sponsor
6 Previous Clinical Trials
174 Total Patients Enrolled
3 Trials studying Wrinkles
74 Patients Enrolled for Wrinkles
Dallas Plastic Surgery InstituteOTHER
2 Previous Clinical Trials
29 Total Patients Enrolled
1 Trials studying Wrinkles
6 Patients Enrolled for Wrinkles
Jill EdgecombeStudy DirectorCytrellis Biosystems, Inc.
~2 spots leftby Sep 2025