RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite (NCT06283056) | Clinical Trial Compass
CompletedNot Applicable
RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite
United States48 participantsStarted 2022-06-16
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Cellulite assessment based on Clinician Reported Photonumeric Cellulite Severity Scale
Timeframe: 6 Months
2
Cellulite assessment based on DiBernardo Photonumeric Cellulite Severity Scale