Microneedling treatment for cellulite

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

This study tests if a new microneedling device can safely reduce cellulite and improve skin tightness in women aged 18-65.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: InMode MD Ltd. (Industry-sponsored)
• Locations: 2 sites (New York, New York and 1 other locations)
• Trial ID: NCT06283056 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the Morpheus 8 Body device, which uses a 40-pin tip to target subdermal layers at depths of up to 7mm for treating cellulite, skin laxity, and subcutaneous fat deposits. Participants will receive two treatments based on the physician's discretion, utilizing different depths or a sequential mode. The study is designed as a prospective, open-label, baseline-controlled trial, focusing on female subjects aged 18-65 with specific BMI and cellulite severity criteria.

Who should consider this trial

Good fit: Ideal candidates are females aged 18-65 with a BMI between 18.5 and 30 and cellulite graded 1-4.

Not a fit: Patients with obesity, severe cellulite (grade 5), or those who have undergone recent aesthetic treatments in the treatment area may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the appearance of cellulite and skin laxity for patients.

How similar studies have performed: While similar microneedling approaches have shown promise in aesthetic treatments, the specific application for cellulite using this device is relatively novel.

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.

Where this trial is running

New York, New York and 1 other locations

• Dermatology & Laser Surgery Center of New York — New York, New York, United States (Active_not_recruiting)
• Dallas Plastic Surgeon — Dallas, Texas, United States (Recruiting)

Study contacts

• Principal investigator: . Macrene Alexiades, md
• Study coordinator: Meital Matalon, Ms

Conditions Cellulitis of Leg