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

NCT04103619 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-01-10

No results posted yet for this study

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)

Conditions

  • Periorbital Edema

Interventions

DEVICE

AccuTite

Subjects will undergo treatment with AccuTite

DEVICE

AccuTite + Morpheus 8

Subjects will undergo treatment with AccuTite and Morpheus 8

Sponsors & Collaborators

  • InMode MD Ltd.

    lead INDUSTRY

Principal Investigators

  • David Holcomb, MD · Holcomb Kreithen Plastic Surgery and MedSpa

  • Richard Gentile, MD · Gentile Facial Plastic and Aesthetic Laser Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
29 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-16
Primary Completion
2021-12-13
Completion
2021-12-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04103619 on ClinicalTrials.gov