Cellulite of Thighs
Conditions
Brief summary
This prospective study is intended to evaluate the CelluTite RFAL handpiece combined with Morpheus8 handpiece for the treatment of cellulite.
Detailed description
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.
Interventions
DEVICECelluTite
CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Sponsors
InMode MD Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will receive the treatment and outcome will be followed
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) | 6 months | 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 |
| Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment) | 6 months | 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. |
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour) | 6 months | 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 |
| Assessment of Adverse Events Occurrence Based on Severity | 3 months | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Subjects receive CelluTite treatment followed by Morpheus8 treatment
CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Continuous | 50.62 years STANDARD_DEVIATION 8.83 |
| Cellulite Score Rated According to Cellulite Severity Scale (Contour) | 3.55 score on a scale STANDARD_DEVIATION 0.69 |
| Cellulite Score Rated According to Cellulite Severity Scale (Dimples) | 3.45 score on a scale STANDARD_DEVIATION 0.69 |
| Race/Ethnicity, Customized Biracial | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 7 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 4 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
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).
Time frame: 1 month
Population: Only subjects completed 1 Month FU were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Assessment of Adverse Events Occurrence Based on Severity | 0 score on a scale | Standard Deviation 0 |
Primary
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).
Time frame: 3 months
Population: Only subjects completed 3 M FU were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Assessment of Adverse Events Occurrence Based on Severity | 0 score | Standard Deviation 0 |
Primary
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).
Time frame: Treatment Day
Population: All subjects undergone treatment were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Assessment of Adverse Events Occurrence Based on Severity | 0.2 score on a scale | Standard Deviation 0.41 |
Primary
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).
Time frame: 6 Months
Population: Only subjects completed 6 M FU were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Assessment of Adverse Events Occurrence Based on Severity | 0 score on a scale | Standard Deviation 0 |
Primary
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).
Time frame: 1 week
Population: Only subjects completed 1 week FU were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Assessment of Adverse Events Occurrence Based on Severity | 0.08 score on a scale | Standard Deviation 0.27 |
Primary
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.
Time frame: 6 months
Population: Only subjects completed 6 months FU were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment) | 0 score | Standard Deviation 0 |
Primary
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.
Time frame: 6 months
Population: Only subjects completed 6 month FU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment) | 0 score | Standard Deviation 0 |
Primary
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.
Time frame: 3 months
Population: Only subjects completed 6 months FU were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment) | 0 score | Standard Deviation 0 |
Primary
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.
Time frame: 1 week
Population: Only subjects completed 1 week FU were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment) | 0.16 score | Standard Deviation 0.55 |
Primary
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.
Time frame: Treatment Day
Population: Only subjects completed treatment were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment) | 0.4 score | Standard Deviation 0.8 |
Primary
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
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour) | 2 score on a scale | Standard Deviation 0.82 |
Primary
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour) | 2.82 score on a scale | Standard Deviation 0.87 |
Primary
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
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour) | 2.89 score on a scale | Standard Deviation 0.93 |
Primary
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour) | 2.64 score on a scale | Standard Deviation 0.92 |
Primary
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) | 2.45 score on a scale | Standard Deviation 1.04 |
Primary
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
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) | 2.6 score on a scale | Standard Deviation 1.07 |
Primary
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) | 2.64 score on a scale | Standard Deviation 0.81 |
Primary
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
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) | 1.9 score on a scale | Standard Deviation 0.99 |