Periorbital EdemaNCT04103619
Energy-Based Lower Eyelid Rejuvenation - Proof of Concept for InMode AccuTite With or Without Morpheus8
A study testing AccuTite and AccuTite + Morpheus 8 in people with Periorbital Edema, run by InMode MD Ltd. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 29 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Periorbital Edema
- What is being tested?
- AccuTite and AccuTite + Morpheus 8
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 May 2019to 13 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult females and males between the ages of 29-75 inclusive, having minimum level 1 for convexity for both lower eyelids.
- The patients should understand the information provided about the investigative nature of the treatment, possible benefits, and side effects, and sign the Informed Consent Form, (including the permission to use photography).
- The patients should be willing to comply with the study procedure and schedule, including the follow-up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period.
Who cannot join
- - Grade 3 lower eyelid convexity
- Grade 3 festoonage
- Prior lower eyelid fat removal (transconjunctival, transcutaneous)
- Prior lower eyelid skin resection
- Full-field or fractional laser skin resurfacing of lower eyelids in the past 24 months
- Tear trough, suborbital, midface filler injections in the past 24 months
Show all 29Show fewer
- Neuromodulator treatment of crow's feet area in the past 12 months
- Lower eyelid malposition (rounding, retraction, ectropion, laxity)
- Meige syndrome
- Significant negative vector lower eyelid
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- The Handpiece should be used at least 1cm away from cochlear implants in the ear.
- Superficial permanent implant in the treated area such as metal plates and screws, metal piercing, silicone implants or an injected chemical substance.
- Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles.
- Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
- Pregnancy and nursing.
- History of bleeding coagulopathies or the use of anticoagulants.
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
- Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.
- Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
- Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
- Any surgery or treatment such as laser or chemicals in the treated area within 3-6 months prior to treatment or before complete healing.
- Allergies, in particular to anesthesia.
- Mental disorders such as Body Dysmorphic Disorder (BDD).
- Monovision (single seeing eye)
- Corneal transplant
- Severe dry eyes
- As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
David Holcomb
Sarasota, Florida, 34237
Gentile Facial Plastic and Aesthetic Laser Center
Youngstown, Ohio, 44512
About this study
- 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).
- 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)
Read the 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).
- 15 patients will receive AccuTite treatment only (7-8 patients per arm at each of the two study sites)
- 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
- Being tested
- AccuTite, AccuTite + Morpheus 8
- Medical subject headings
- Orbital Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuTiteDevice
Subjects will undergo treatment with AccuTite
AccuTite + Morpheus 8Device
Subjects will undergo treatment with AccuTite and Morpheus 8
| Study group | Role | What they receive |
|---|---|---|
| AccuTite | Active comparator | 15 patients will receive AccuTite treatment only Receives: Device: AccuTite |
| AccuTite & Morpheus 8 Arm | Active comparator | 15 patients will receive AccuTite and Morpheus8 treatment and additional 2 monthly Morpheus8 treatments Receives: Device: AccuTite + Morpheus 8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 3 and 6 months
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
Measured: Change from baseline at 3 and 6 months
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
Measured: Change from baseline at 3 and 6 months
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
Measured: Change from baseline at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start16 May 2019
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periorbital EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Holcomb, MD, Principal investigator, Holcomb Kreithen Plastic Surgery and MedSpaRichard Gentile, MD, Principal investigator, Gentile Facial Plastic and Aesthetic Laser Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103619
- Sponsor's protocol ID
- DO608677A
- Status last verified
- Jan 2022
- First submitted
- 23 Sep 2019
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy-Based Lower Eyelid Rejuvenation - Proof of Concept for InMode AccuTite With or Without Morpheus8
- ClinicalTrials.gov ID
- NCT04103619
- Acronym / sponsor ID
- DO608677A
- Conditions
- Periorbital Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 May 2019 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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).
- 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).
- 15 patients will receive AccuTite treatment only (7-8 patients per arm at each of the two study sites)
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AccuTite | Active comparator | Device: AccuTite15 patients will receive AccuTite treatment only |
| AccuTite & Morpheus 8 Arm | Active comparator | Device: AccuTite + Morpheus 815 patients will receive AccuTite and Morpheus8 treatment and additional 2 monthly Morpheus8 treatments |
Who may qualify
- Ages
- 29 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult females and males between the ages of 29-75 inclusive, having minimum level 1 for convexity for both lower eyelids.
- The patients should understand the information provided about the investigative nature of the treatment, possible benefits, and side effects, and sign the Informed Consent Form, (including the permission to use photography).
- The patients should be willing to comply with the study procedure and schedule, including the follow-up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period.
Key exclusion criteria (29 listed)
- - Grade 3 lower eyelid convexity
- Grade 3 festoonage
- Prior lower eyelid fat removal (transconjunctival, transcutaneous)
- Prior lower eyelid skin resection
- Full-field or fractional laser skin resurfacing of lower eyelids in the past 24 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccuTiteSubjects will undergo treatment with AccuTite | Device | AccuTite |
| AccuTite + Morpheus 8Subjects will undergo treatment with AccuTite and Morpheus 8 | Device | AccuTite & Morpheus 8 Arm |
Primary outcome
Correct identification at baseline and post treatment pictures
Time frame: Change from baseline at 3 and 6 months
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 in lower eyelid convexity scale
Time frame: Change from baseline at 3 and 6 months
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 1. = mild convexity lower eyelid 2. = moderate convexity lower eyelid 3. = severe convexity lower eyelid
Change in Festoonage scale
Time frame: Change from baseline at 3 and 6 months
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 1. = single skin fold at or below inferior orbital rim 2. = double skin fold at or below inferior orbital rim 3. = triple skin fold at or below inferior orbital rim
Subject assessment of satisfaction
Time frame: Change from baseline at 3 and 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Holcomb, MD principal investigator
Holcomb Kreithen Plastic Surgery and MedSpa
Richard Gentile, MD principal investigator
Gentile Facial Plastic and Aesthetic Laser Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AccuTite and AccuTite + Morpheus 8 in people with Periorbital Edema, run by InMode MD Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct identification at baseline and post treatment pictures (time frame: Change from baseline at 3 and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.