Clinical trial NCT06283056: RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite
Official title: Radiofrequency Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cellulitis of Leg
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, open-label clinical study.
Primary purpose: TREATMENT

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.

Detailed 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.

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.

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.

Primary outcomes:
measure: Cellulite assessment based on Clinician Reported Photonumeric Cellulite Severity Scale
timeFrame: 6 Months
measure: Cellulite assessment based on DiBernardo Photonumeric Cellulite Severity Scale
timeFrame: 6 Months
Secondary outcomes:
measure: Subject assessment of improvement
timeFrame: 1 month
measure: Subject assessment of improvement
timeFrame: 3 months
measure: Subject assessment of improvement
timeFrame: 6 months
measure: Subject assessment of satisfaction
timeFrame: 1 month
measure: Subject assessment of satisfaction
timeFrame: 3 months
measure: Subject assessment of satisfaction
timeFrame: 6 months
measure: Investigator assessment of the skin appearance improvemen
timeFrame: 1 month
measure: Investigator assessment of the skin appearance improvement
timeFrame: 3 months
measure: Investigator assessment of the skin appearance
timeFrame: 6 months
measure: Investigator assessment of the cellulite following subdermal Morpheus8 treatment
timeFrame: 1 Month
measure: Investigator assessment of the cellulite following subdermal Morpheus8 treatment
timeFrame: 3 Months
measure: Investigator assessment of the cellulite following subdermal Morpheus8 treatment
timeFrame: 6 Months
Other outcomes:
measure: Adverse Event rate
timeFrame: For the duration of the study
measure: Pain Scale
timeFrame: Immediately post each procedure
Locations:
city: New York
country: United States
facility: Dermatology & Laser Surgery Center of New York
state: New York
city: Dallas
country: United States
facility: Dallas Plastic Surgeon
state: Texas
Study officials:
name: . Macrene Alexiades, md
role: PRINCIPAL_INVESTIGATOR
name: Rod Rohrich, md
role: PRINCIPAL_INVESTIGATOR
References: