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

Launched by INMODE MD LTD. · Feb 21, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for cellulite, which is the dimpled appearance of skin, often found on the legs. The study aims to assess how safe and effective a technique called RF microneedling is when using a special device called Morpheus 8 Body. This device targets the deeper layers of the skin to help improve the look of cellulite, tighten loose skin, and reduce fat deposits.

To participate in this trial, women between the ages of 18 and 65 who have a body mass index (BMI) between 18.5 and 30 (which means they are normal to overweight but not obese) may be eligible, as long as they have cellulite graded from mild to moderate. Participants will need to agree to follow the study’s procedures, including attending follow-up visits, and will need to avoid other cosmetic treatments in the area being treated for a certain period. It’s important for interested individuals to discuss their health history with the study team to ensure they meet the eligibility criteria.

Gender

FEMALE

Eligibility criteria

• 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.