Status:
COMPLETED
Healing Study of Fractional Skin Resurfacing and Tissue Histopathology After Ellacor Treatment
Lead Sponsor:
Cytrellis Biosystems, Inc.
Collaborating Sponsors:
Dallas Plastic Surgery Institute
Conditions:
Wrinkle
Rhytides
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 area...
Eligibility Criteria
Inclusion
- Undergoing planned abdominoplasty
- Are willing to donate their tissue for evaluation
- BMI ≤ 30
- Women 18 years or older
- Fitzpatrick scale I-VI
- Females of childbearing potential will have a negative urine pregnancy test prior to each procedure
- Are judged to be in good health based on the results of a medical history and physical examination (standard of care for abdominoplasty) at screening
- Has been informed of the nature of the study and agrees to its provisions and has provided written informed consent on a form, as approved by the IRB of the respective clinical site.
- Able and willing to comply with all visits, procedures and evaluation schedules and requirements
Exclusion
- Having an active bleeding disorder or currently taking anticoagulants
- History of keloid formation or abnormal wound healing
- Inflammation or active infection and treatment area
- Compromised immune system (e.g., diabetes)
- Any surgery or treatments in the abdominal area 12 months prior to procedure
- Comorbid condition that could limit ability to participate in the study or to comply with follow up requirements
- Pregnant or breastfeeding
- Tattoo and/or mole located within the planned treatment area(s)
- Vulnerable populations include those defined 45 CFR 46 Subparts B, and those mentioned in 45 CFR 46.111(b): mentally disabled persons, or economically or educationally disadvantaged persons
- Any issue that at the discretion of the investigator would contraindicate the subject's participation
Key Trial Info
Start Date :
April 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT06502470
Start Date
April 30 2024
End Date
May 17 2024
Last Update
July 16 2024
Active Locations (1)
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1
Dallas Plastic Surgery Institute
Dallas, Texas, United States, 75231