N/A
N=16
Post-Market Lower Eyelid Treatment With Renuvion in Greece
Skin Laxity
Bottom Line
View on ClinicalTrials.gov: NCT05605691 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Day 180 Number of Participants With Improvement in Lower Eyelid Area as Determined by a Masked, Qualitative Assessment. — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Renuvion APR System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Apyx Medical
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Day 180 Number of Participants With Improvement in Lower Eyelid Area as Determined by a Masked, Qualitative Assessment. |
5 | — |
| SECONDARY Day 90 Number of Participants With Improvement in the Lower Eyelid Area as Determined by a Masked, Qualitative Assessment. |
8 | — |
Summary
This is a prospective, multi-center, non-randomized, single-arm study of up to 15 subjects treated with the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System in the lower periorbital area on both sides of the face.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects, ages 18 - 75 years old.
- ASA Physical Status Classification System Class I and Class II subjects.
- Complaint of skin laxity or lines in the lower eyelid area.
- Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.
- Absence of physical conditions unacceptable to the investigator.
- Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
- Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.
- Willing to release rights for the use of study photos, including in publication.
- Able to read, understand, sign, and date the informed consent.
- Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit.
Exclusion Criteria
- Subjects presenting with ASA Physical Status Classification System Classes III or higher.
- Festoons in the periorbital area.
- Prior cosmetic/aesthetic fillers (hyaluronic acid, poly-l-lactic acid, calcium hydroxylapatite, et.) in the study treatment area within the past 12 months.
- Pregnant, lactating, or plans to become pregnant during study participation.
- Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine).
- Known hypersensitivity or allergy to ibuprofen or other NSAIDS.
- Previous surgery in the study treatment area.
- Active systemic or local skin disease that may alter wound healing.
- Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.
- History of autoimmune disease (excluding Hashimoto's thyroiditis).
- Known susceptibility to keloid formation or hypertrophic scarring.
- Cancerous or pre-cancerous lesions in the area to be treated.
- Possesses a surgically implanted electronic device (i.e., pacemaker).
- Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
- Participation in any other investigational study within 30 days prior to consent and throughout study participation.
- Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.
Data sourced from ClinicalTrials.gov (NCT05605691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.