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

NCT06283056 | Completed FDA Device

• 1 other identifier: DO611073A
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Cellulitis of Leg

Outcome Measures

Primary Outcomes (2)

• 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 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

  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

  6 Months

Secondary Outcomes (12)

• Subject assessment of improvement

  1 month

• Subject assessment of improvement

  3 months

• Subject assessment of improvement

  6 months

• Subject assessment of satisfaction

  1 month

• Subject assessment of satisfaction

  3 months

Other Outcomes (2)

• Adverse Event rate

  For the duration of the study

• Pain Scale

  Immediately post each procedure

Study Arms (1)

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.

Device: Device treatment

Interventions

Device treatment DEVICE

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.

Device Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: 40 female subjects aged 18-65 seeking cellulite treatment. Treatment areas include: thighs.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (2)

Dermatology & Laser Surgery Center of New York

New York, New York, 10028, United States

Location

Dallas Plastic Surgeon

Dallas, Texas, 75225, United States

Location

Study Officials

• . Macrene Alexiades, md

  PRINCIPAL INVESTIGATOR

• Rod Rohrich, md

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open-label clinical study.

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: February 28, 2024
• Study Start: June 16, 2022
• Primary Completion: October 2, 2024
• Study Completion: April 1, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-06

Locations

US (2)