NCT04103619

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: InMode MD Ltd. · Industry
• Sex: All
• Age: 29 Years – 75 Years
• Healthy volunteers: Accepted

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)

Detailed 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

Conditions

• Periorbital Edema

Interventions

Type	Name	Description
DEVICE	AccuTite	Subjects will undergo treatment with AccuTite
DEVICE	AccuTite + Morpheus 8	Subjects will undergo treatment with AccuTite and Morpheus 8

Timeline

• Start date: 2019-05-16
• Primary completion: 2021-12-13
• Completion: 2021-12-13
• First posted: 2019-09-25
• Last updated: 2022-01-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study