Post-Market Lower Eyelid Treatment With Renuvion in Greece (NCT05605691) | Clinical Trial Compass
CompletedNot Applicable
Post-Market Lower Eyelid Treatment With Renuvion in Greece
Greece16 participantsStarted 2022-10-11
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 ibu…
What they're measuring
1
Day 180 Number of Participants With Improvement in Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.