Cellulitis of Leg
Conditions
Brief 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.
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.
Interventions
DEVICEDevice 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.
Sponsors
InMode MD Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, open-label clinical study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cellulite assessment based on Clinician Reported Photonumeric Cellulite Severity Scale | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject assessment of improvement | 1 month | 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 |
| Subject assessment of satisfaction | 1 month | 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 |
| Investigator assessment of the skin appearance improvemen | 1 month | 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. |
| Investigator assessment of the skin appearance improvement | 3 months | 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 |
| Investigator assessment of the skin appearance | 6 months | 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 |
| Investigator assessment of the cellulite following subdermal Morpheus8 treatment | 1 Month | 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%) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOR. Macrene Alexiades, md
PRINCIPAL_INVESTIGATORRod Rohrich, md
Outcome results
None listed