Cellulitis of LegNCT06283056
RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite
A study testing Device treatment in people with Cellulitis of Leg, run by InMode MD Ltd. at 2 sites in United States.
Trial summary
The aim of the study is to evaluate the safety and efficacy of Morpheus 8 Body 40-pin tip up to 7mm depth Applicator for subdermal treatment of cellulite appearance, skin laxity, and subcutaneous fat deposits. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulitis of Leg
- What is being tested?
- Device treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jun 2022to 1 Apr 2025
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female subjects aged 18-65 (inclusive)
- BMI interval: 18.5 ≤ BMI ≤ 30 (normal to overweight, but not obese).
- Subject having cellulite grade 1-4 as graded using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS)7.
- The patients should understand the information provided about 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 (i.e liposuction, any cellulite/circumference reduction treatments using medical devices, etc.) in the treatment area for the last 6 months and during the entire study period.
- Females of Childbearing potential must be using an approved method of birth control. Subjects who are capable of becoming pregnant will undergo a urine pregnancy test.
Who cannot join
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- Superficial permanent implant in the treated area such as metal plates and screws, metal piercing, silicone implants or an injected chemical substance.
- Known sensitivity/allergy to Lidocaine
- 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 or lactating.
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- History of bleeding coagulopathies or use of anticoagulants.
- Chronic or current use of NSAIDs or other anti-inflammatory therapies (e.g., Ibuprofen, etc.)
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
- Any uncontrolled medical condition (i.e., endocrine disorders, diabetes, thyroid disfunction or hormonal virilization) that in the opinion of the investigator, the subject's safety may be compromised.
- 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 treated area within 3-6 months prior to treatment or before complete healing.
- Any medical condition that in the opinion of the investigator, such condition would compromise the safety of the subject or quality of the study data.
- Current, or past participation in a clinical trial within the past 30 days.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dallas Plastic Surgeon
Dallas, Texas, 75225
Dermatology & Laser Surgery Center of New York
New York, New York, 10028
About this study
Official title: Radiofrequency Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite
The aim of the study is to evaluate the safety and efficacy of Morpheus 8 Body 40-pin tip up to 7mm depth Applicator for subdermal treatment of cellulite appearance, skin laxity, and subcutaneous fat deposits.
Read the detailed description
The aim of the study is to evaluate the safety and efficacy of Morpheus 8 Body 40-pin tip up to 7mm depth Applicator for subdermal treatment of cellulite appearance, skin laxity, and subcutaneous fat deposits.
Prospective, open-label, baseline-controlled, clinical study to evaluate the Morpheus8 device for treatment of cellulite, skin laxity, and subcutaneous fat deposits of the thighs.
Eligible subjects will undergo two treatments with the Morpheus8 device using the 3, 5 7 mm depths or sequential (Burst) mode, based on the treating physician's discretion.
- Conditions
- Cellulitis of Leg
- Being tested
- Device treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device treatmentDevice
InMode RF system with Morpheus8 Body (up to 7mm depth) Eligible subjects will undergo two treatments with the Morpheus8 device using the 3, 5 7 mm depths or sequential (Burst) mode, based on the treating physician's discretion..each subject is approximately 9 months (including screening, two treatments (2 months apart) and 3 follow-up visits at 1 month, 3 months, and 6 months post treatment.
| Study group | Role | What they receive |
|---|---|---|
| Device Treatment | Experimental | Eligible subjects will undergo two treatments with the Morpheus8 device using the 3, 5 7 mm depths or sequential (Burst) mode, based on the treating physician's discretion. Receives: Device: Device treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellulite assessment based on Clinician Reported Photonumeric Cellulite Severity Scale
Cellulite assessment based on Clinician Reported Photonumeric Cellulite Severity Scale (using pre (baseline) and post treatment Standard medical photography, having at least mean of one-unit improvement (1-point score reduction).
0 - None - No evident cellulite
- - Almost none - A few superficial dimples or ridges
- - Mild - Several dimples or ridges, of which most are superficial
- - Moderate - Many dimples or ridges, of which more are somewhat deep
- - Severe - A lot of dimples or ridges, of which many are deep, covering most of the skin area
Measured: 6 Months
Cellulite assessment based on DiBernardo Photonumeric Cellulite Severity Scale
Cellulite assessment based on DiBernardo Photonumeric Cellulite Severity Scale using pre (baseline) and post-treatment Standard medical photography, having at least a mean of one-unit improvement (1-point score reduction).
This 5-point photo numeric scale rates cellulite severity from "0" (none) to "4" (severe) from a clinician's perspective
Measured: 6 Months
Secondary outcomes (12)
Subject assessment of improvement
Subject assessment of improvement using 0 - 4 -points Likert scale at 1 month, 3 months, 6 months follow up visits:
4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No change
Measured: 1 month
Subject assessment of improvement
Subject assessment of improvement using 0 - 4 -points Likert scale at 1 month, 3 months, 6 months follow up visits:
4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No change
Measured: 3 months
Subject assessment of improvement
Subject assessment of improvement using 0 - 4 -points Likert scale at 1 month, 3 months, 6 months follow up visits:
4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No change
Measured: 6 months
Subject assessment of satisfaction
Subject assessment of satisfaction will be filled-out by subjects only using 4-points Likert scale at 1 month, 3 months, 6 months follow up visits:
+2 = Very satisfied; +1 = Satisfied; -1 = Dissatisfied; -2 = Very Dissatisfied
Measured: 1 month
Subject assessment of satisfaction
Subject assessment of satisfaction will be filled-out by subjects only using 4-points Likert scale at 1 month, 3 months, 6 months follow up visits:
+2 = Very satisfied; +1 = Satisfied; -1 = Dissatisfied; -2 = Very Dissatisfied
Measured: 3 months
Subject assessment of satisfaction
Subject assessment of satisfaction will be filled-out by subjects only using 4-points Likert scale at 1 month, 3 months, 6 months follow up visits:
+2 = Very satisfied; +1 = Satisfied; -1 = Dissatisfied; -2 = Very Dissatisfied
Measured: 6 months
Investigator assessment of the skin appearance improvemen
Investigator assessment of the skin appearance improvement comparing pre and post treatment using Global aesthetic improvement 4-point grading scale (0=No tightening/firmness, 1= Slightly visible tightening/firmness, 2= Visible tightening/firmness, 3= Very visible tightening/firmness) at all follow up visits.
Measured: 1 month
Investigator assessment of the skin appearance improvement
Investigator assessment of the skin appearance improvement comparing pre and post treatment using 0 - 4 -points Likert scale at 1 month, 3 months, 6 months follow up visits:
4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference
Measured: 3 months
Investigator assessment of the skin appearance
Investigator assessment of the skin appearance improvement comparing pre and post treatment using 0 - 4 -points Likert scale at 1 month, 3 months, 6 months follow up visits:
4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference
Measured: 6 months
Investigator assessment of the cellulite following subdermal Morpheus8 treatment
Statistically significant improvement in global aesthetic appearance of cellulite, as assessed by PI using Global aesthetic improvement 5-point grading scale (0=No change, 1=1%-24%%, 2=25%-49%, 3=50%-74% improvement, and 4=75%-100%)
Measured: 1 Month
Investigator assessment of the cellulite following subdermal Morpheus8 treatment
Statistically significant improvement in global aesthetic appearance of cellulite, as assessed by PI using Global aesthetic improvement 5-point grading scale (0=No change, 1=1%-24%%, 2=25%-49%, 3=50%-74% improvement, and 4=75%-100%)
Measured: 3 Months
Investigator assessment of the cellulite following subdermal Morpheus8 treatment
Statistically significant improvement in global aesthetic appearance of cellulite, as assessed by PI using Global aesthetic improvement 5-point grading scale (0=No change, 1=1%-24%%, 2=25%-49%, 3=50%-74% improvement, and 4=75%-100%)
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start16 Jun 2022
- Primary completion2 Oct 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cellulitis of LegStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open-label clinical study.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- . Macrene Alexiades, md, Principal investigatorRod Rohrich, md, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283056
- Sponsor's protocol ID
- DO611073A
- Status last verified
- Jul 2026
- First submitted
- 16 Nov 2023
- Last updated
- 30 Jul 2026
- 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite
- ClinicalTrials.gov ID
- NCT06283056
- Acronym / sponsor ID
- DO611073A
- Conditions
- Cellulitis of Leg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 28 Feb 2024 (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.
The aim of the study is to evaluate the safety and efficacy of Morpheus 8 Body 40-pin tip up to 7mm depth Applicator for subdermal treatment of cellulite appearance, skin laxity, and subcutaneous fat deposits.
Detailed description
The aim of the study is to evaluate the safety and efficacy of Morpheus 8 Body 40-pin tip up to 7mm depth Applicator for subdermal treatment of cellulite appearance, skin laxity, and subcutaneous fat deposits.
Prospective, open-label, baseline-controlled, clinical study to evaluate the Morpheus8 device for treatment of cellulite, skin laxity, and subcutaneous fat deposits of the thighs.
Eligible subjects will undergo two treatments with the Morpheus8 device using the 3, 5 7 mm depths or sequential (Burst) mode, based on the treating physician's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open-label clinical study.
| Arm | Type | Receives |
|---|---|---|
| Device Treatment | Experimental | Device: Device treatmentEligible subjects will undergo two treatments with the Morpheus8 device using the 3, 5 7 mm depths or sequential (Burst) mode, based on the treating physician's discretion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female subjects aged 18-65 (inclusive)
- BMI interval: 18.5 ≤ BMI ≤ 30 (normal to overweight, but not obese).
- Subject having cellulite grade 1-4 as graded using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS)7.
- The patients should understand the information provided about 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 (i.e liposuction, any cellulite/circumference reduction treatments using medical devices, etc.) in the treatment area for the last 6 months and during the entire study period.
Key exclusion criteria (16 listed)
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- Superficial permanent implant in the treated area such as metal plates and screws, metal piercing, silicone implants or an injected chemical substance.
- Known sensitivity/allergy to Lidocaine
- 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.
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 |
|---|---|---|
| Device treatmentInMode RF system with Morpheus8 Body (up to 7mm depth) Eligible subjects will undergo two treatments with the Morpheus8 device using the 3, 5 7 mm depths or sequential (Burst) mode, based on the treating physician's discretion..each subject is approximately 9 months (including screening, two treatments (2 months apart) and 3 follow-up visits at 1 month, 3 months, and 6 months post treatment. | Device | Device Treatment |
Primary outcome
Cellulite assessment based on Clinician Reported Photonumeric Cellulite Severity Scale
Time frame: 6 Months
Cellulite assessment based on Clinician Reported Photonumeric Cellulite Severity Scale (using pre (baseline) and post treatment Standard medical photography, having at least mean of one-unit improvement (1-point score reduction). 0 - None - No evident cellulite 1. - Almost none - A few superficial dimples or ridges 2. - Mild - Several dimples or ridges, of which most are superficial 3. - Moderate - Many dimples or ridges, of which more are somewhat deep 4. - Severe - A lot of dimples or ridges, of which many are deep, covering most of the skin area
Cellulite assessment based on DiBernardo Photonumeric Cellulite Severity Scale
Time frame: 6 Months
Cellulite assessment based on DiBernardo Photonumeric Cellulite Severity Scale using pre (baseline) and post-treatment Standard medical photography, having at least a mean of one-unit improvement (1-point score reduction). This 5-point photo numeric scale rates cellulite severity from "0" (none) to "4" (severe) from a clinician's perspective
12 secondary outcomes
Subject assessment of improvement
Time frame: 1 month
Subject assessment of improvement
Time frame: 3 months
Subject assessment of improvement
Time frame: 6 months
Subject assessment of satisfaction
Time frame: 1 month
Subject assessment of satisfaction
Time frame: 3 months
Subject assessment of satisfaction
Time frame: 6 months
Investigator assessment of the skin appearance improvemen
Time frame: 1 month
Investigator assessment of the skin appearance improvement
Time frame: 3 months
Investigator assessment of the skin appearance
Time frame: 6 months
Investigator assessment of the cellulite following subdermal Morpheus8 treatment
Time frame: 1 Month
Investigator assessment of the cellulite following subdermal Morpheus8 treatment
Time frame: 3 Months
Investigator assessment of the cellulite following subdermal Morpheus8 treatment
Time frame: 6 Months
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 30 Jul 2026.
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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.
. Macrene Alexiades, md principal investigator
Rod Rohrich, md principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device treatment in people with Cellulitis of Leg, 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 6 inclusion and 16 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 30 Jul 2026. 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?
Cellulite assessment based on Clinician Reported Photonumeric Cellulite Severity Scale (time frame: 6 Months). The study lists 2 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 30 Jul 2026.