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Completed

NCT Number: NCT06283056

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

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.

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Key information

Conditions

Cellulitis of Leg

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology & Laser Surgery Center of New York, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Cellulite assessment based on Clinician Reported Photonumeric Cellulite Severity Scale

    Time frame: 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

    • - 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

  2. Cellulite assessment based on DiBernardo Photonumeric Cellulite Severity Scale

    Time frame: 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 outcomes

  1. Subject assessment of improvement

    Time frame: 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

  2. Subject assessment of improvement

    Time frame: 3 months

    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. Subject assessment of improvement

    Time frame: 6 months

    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

  4. Subject assessment of satisfaction

    Time frame: 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

  5. Subject assessment of satisfaction

    Time frame: 3 months

    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. Subject assessment of satisfaction

    Time frame: 6 months

    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

  7. Investigator assessment of the skin appearance improvemen

    Time frame: 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.

  8. Investigator assessment of the skin appearance improvement

    Time frame: 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

  9. Investigator assessment of the skin appearance

    Time frame: 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

  10. Investigator assessment of the cellulite following subdermal Morpheus8 treatment

    Time frame: 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%)

  11. Investigator assessment of the cellulite following subdermal Morpheus8 treatment

    Time frame: 3 Months

    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%)

  12. Investigator assessment of the cellulite following subdermal Morpheus8 treatment

    Time frame: 6 Months

    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%)

Other outcomes

  1. Adverse Event rate

    Time frame: For the duration of the study

    Rate of all device and procedure related adverse events (AE's) and serious adverse events (SAE's) occurring during the study

  2. Pain Scale

    Time frame: Immediately post each procedure

    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

Sponsors and collaborators

Lead sponsor

InMode MD Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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