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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04103619
Other study ID # DO608677A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 16, 2019
Est. completion date December 13, 2021

Study information

Verified date January 2022
Source InMode MD Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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)


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


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
AccuTite
Subjects will undergo treatment with AccuTite
AccuTite + Morpheus 8
Subjects will undergo treatment with AccuTite and Morpheus 8

Locations

Country Name City State
United States David Holcomb Sarasota Florida
United States Gentile Facial Plastic and Aesthetic Laser Center Youngstown Ohio

Sponsors (1)

Lead Sponsor Collaborator
InMode MD Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correct identification at baseline and post treatment pictures Correct identification of the 3 and 6 Months post last treatment photographs from the baseline by at least two of the three blinded reviewers in 75% of the subjects. Change from baseline at 3 and 6 months
Primary Change in lower eyelid convexity scale Investigator assessment of the Lower eyelid convexity scale (based on right and left lateral photography assessments with Canfield Scientific imaging) at 3 and 6 months follow up visit and compared to the baseline, as follows: 0 = flat lower eyelid
= mild convexity lower eyelid
= moderate convexity lower eyelid
= severe convexity lower eyelid
Change from baseline at 3 and 6 months
Primary Change in Festoonage scale Investigator assessment of the Festoonage scale (based on photography assessments with Canfield Scientific imaging TBD) at 3 and 6 months follow up visit and compared to the baseline, as follows: 0 = no skin fold at or below inferior orbital rim
= single skin fold at or below inferior orbital rim
= double skin fold at or below inferior orbital rim
= triple skin fold at or below inferior orbital rim
Change from baseline at 3 and 6 months
Primary Subject assessment of satisfaction Subject assessment of satisfaction will be filled out by subjects using a 5-points
Likert scale at 3 and 6 months follow up, as follows:
+2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very disappointed
Change from baseline at 3 and 6 months
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