Energy-Based Lower Eyelid Rejuvenation - Proof of Concept for InMode AccuTite With or Without Morpheus8

Periorbital Edema Clinical Trial

Official title: Energy-Based Lower Eyelid Rejuvenation - Proof of Concept for InMode AccuTite With or Without Morpheus8

Status Completed

Clinical Trial Summary

1. To establish clinical efficacy, safety and patient satisfaction of reducing lower eyelid convexities or "bags" and/or malar crescents (festoons) with catheter-based injectable RF (InMode AccuTite) and variable depth Fractional RF Microneedle skin rejuvenation (InMode Morpheus8).

2. To determine the relative effectiveness of dual-modality treatment (AccuTite + Morphues8 initial treatment followed by two consecutive Morpheus8 treatments 1 month apart) versus single modality treatment (AccuTite only)

Clinical Trial Description

This prospective study is intended to evaluate the efficacy of radio frequency energy in reducing lower eyelid convexities or "bags" and/or malar crescents (festoons) with RFAL (InMode AccuTite) and variable depth Fractional RF resurfacing skin rejuvenation (InMode Morpheus8).

1. 15 patients will receive AccuTite treatment only (7-8 patients per arm at each of the two study sites)

2. 15 patients will receive AccuTite and Morpheus8 treatment and additional 2 monthly Morpheus8 treatments (7-8 patients per arm at each of the two study sites) Treatment areas include: periorbital zones with Morpheus8/Lower Eyelid with Accutite ;

Related Conditions & MeSH terms

• Periorbital Edema

• NCT number: NCT04103619
• Study type: Interventional
• Source: InMode MD Ltd.
• Status: Completed
• Phase: N/A
• Start date: May 16, 2019
• Completion date: December 13, 2021