COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-06-16

Study Completion:2025-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06283056

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

. Macrene Alexiades, md

PRINCIPAL_INVESTIGATOR

Rod Rohrich, md

PRINCIPAL_INVESTIGATOR

Study Locations (Sites)

Dermatology & Laser Surgery Center of New York

New York, New York, 10028

United States

Dallas Plastic Surgeon

Dallas, Texas, 75225

United States

Collaborators and Investigators

Sponsor: InMode MD Ltd.

. Macrene Alexiades, md, PRINCIPAL_INVESTIGATOR
Rod Rohrich, md, PRINCIPAL_INVESTIGATOR

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-16

Study Completion Date2025-04-01

Study Record Updates

Study Start Date2022-06-16

Study Completion Date2025-04-01

Terms related to this study

Additional Relevant MeSH Terms

Cellulitis of Leg