Clinical Evaluation of CelluTite Treatment

Study Overview
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Brief Summary
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This prospective study is intended to evaluate the CelluTite RFAL handpiece combined with Morpheus8 handpiece for the treatment of cellulite.

Detailed Description
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The study will evaluate the safety and efficacy of cellulite treatment using two hand pieces: The CelluTite - based on a minimally invasive, temperature-controlled Radiofrequency-assisted lipolysis (RFAL) technology. RF energy is applied using a handpiece with 2 electrodes: internal active electrode with spatula-shaped tip and external electrode. The Morpheus8 - designed to deliver RF energy to the skin surface in a fractional manner via an array of 24-electrode pins.

Official Title
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Clinical Evaluation of Safety and Efficacy of the CelluTite Treatment

Conditions
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Cellulite of Thighs

Intervention / Treatment
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* Device: CelluTite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subjects aged 18-70 having mild/moderate grade cellulites. 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 in the treatment area for the last 6 months and during the entire study period. Exclusion Criteria: Body fat layer thinner than 5mm. 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. 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. History of bleeding coagulopathies or use of anticoagulants. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications. Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization. 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. Allergies, in particular to anesthesia. Mental disorders such as Body Dysmorphic Disorder (BDD). As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects will receive the treatment and outcome will be followed
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Subjects receive CelluTite treatment followed by Morpheus8 treatment | Device: CelluTite<br>* CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF<br>* Other names: Morpheus8;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) | Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome | 6 months | 
| Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment) | Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome. | 6 months | 
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour) | Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome | 6 months | 
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour) | Photos from 1month follow-up visits will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome | 1 month | 
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour) | Photos from 3 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome | 3 months | 
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) | Photos 1 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome | 1 month | 
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) | Photos 3 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome | 3 months | 
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) | Photos 1 week follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome | 1 week | 
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour) | Photos from 1 week ollow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome | 1 week | 
| Assessment of Adverse Events Occurrence Based on Severity | Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3). | 3 months | 
| Assessment of Adverse Events Occurrence Based on Severity | Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3). | 1 month | 
| Assessment of Adverse Events Occurrence Based on Severity | Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3). | 1 week | 
| Assessment of Adverse Events Occurrence Based on Severity | Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3). | Treatment Day | 
| Assessment of Adverse Events Occurrence Based on Severity | Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3). | 6 Months | 
| Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment) | Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome. | 3 months | 
| Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment) | Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome. | 1 week | 
| Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment) | Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome. | Treatment Day |