RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite

Cellulitis of Leg Clinical Trial

Official title:

Radiofrequency Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06283056
• Other study ID #: DO611073A
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: November 2023
• Source: InMode MD Ltd.
• Contact: MEITAL MATALON, MS
• Phone: 14165596503
• Email: meital.matalon[@]inmodemd.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Related Conditions & MeSH terms

• Cellulite
• Cellulitis
• Cellulitis of Leg

Intervention

Device:
• Device treatment
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.

Locations

Country	Name	City	State
United States	Dallas Plastic Surgeon	Dallas	Texas
United States	Dermatology & Laser Surgery Center of New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
InMode MD Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Event rate	Rate of all device and procedure related adverse events (AE's) and serious adverse events (SAE's) occurring during the study	For the duration of the study
Other	Pain Scale	Pain assessment will be performed immediately post treatment using Numeric Pain Rating Scale (NPRS) from 0 to 10. 0 = no pain 10 - worst possible pain	Immediately post each procedure
Primary	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	6 Months
Primary	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	6 Months
Secondary	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	1 month
Secondary	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	3 months
Secondary	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	6 months
Secondary	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	1 month
Secondary	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	3 months
Secondary	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	6 months
Secondary	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.	1 month
Secondary	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	3 months
Secondary	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	6 months
Secondary	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%)	1 Month
Secondary	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%)	3 Months
Secondary	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%)	6 Months