RF Microneedling With Multi-Depth Targeting Per Insertion... | NCT06283056

NCT06283056

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 - 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	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

Measure	Description	Time Frame
Subject assessment of improvement	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	1 month
Subject assessment of improvement

Other Outcomes

Measure	Description	Time Frame
Adverse Event rate	Rate of all device and procedure related adverse events (AE's) and serious adverse events (SAE's) occurring during the study	For the duration of the study
Pain Scale	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

Eligibility Module

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.

Name	Affiliation	Role
. Macrene Alexiades, md		Principal Investigator
Rod Rohrich, md		Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Dermatology & Laser Surgery Center of New York		New York	New York	10028	United States
Dallas Plastic Surgeon