Trial Outcomes & Findings for Clinical Evaluation of CelluTite Treatment (NCT NCT03769649)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

6 months

Results posted on

2022-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Overall Study STARTED	15
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Arm Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Overall Study Lost to Follow-up	4

Baseline Characteristics

Clinical Evaluation of CelluTite Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=11 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Age, Continuous	50.62 years STANDARD_DEVIATION 8.83 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White Non-Hispanic	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=5 Participants
Race/Ethnicity, Customized Biracial	1 Participants n=5 Participants
Cellulite Score Rated According to Cellulite Severity Scale (Dimples)	3.45 score on a scale STANDARD_DEVIATION 0.69 • n=5 Participants
Cellulite Score Rated According to Cellulite Severity Scale (Contour)	3.55 score on a scale STANDARD_DEVIATION 0.69 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Treatment Arm n=11 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)	2.45 score on a scale Standard Deviation 1.04

PRIMARY outcome

Timeframe: 6 months

Population: Only subjects completed 6 month FU

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.

Outcome measures

Outcome measures
Measure	Treatment Arm n=12 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)	0 score Standard Deviation 0

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Treatment Arm n=11 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)	2.64 score on a scale Standard Deviation 0.92

PRIMARY outcome

Timeframe: 1 month

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

Outcome measures

Outcome measures
Measure	Treatment Arm n=11 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)	2.89 score on a scale Standard Deviation 0.93

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome measures
Measure	Treatment Arm n=11 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)	2.82 score on a scale Standard Deviation 0.87

PRIMARY outcome

Timeframe: 1 month

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

Outcome measures

Outcome measures
Measure	Treatment Arm n=11 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)	2.6 score on a scale Standard Deviation 1.07

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome measures
Measure	Treatment Arm n=11 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)	2.64 score on a scale Standard Deviation 0.81

PRIMARY outcome

Timeframe: 1 week

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

Outcome measures

Outcome measures
Measure	Treatment Arm n=11 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)	1.9 score on a scale Standard Deviation 0.99

PRIMARY outcome

Timeframe: 1 week

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

Outcome measures

Outcome measures
Measure	Treatment Arm n=11 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)	2 score on a scale Standard Deviation 0.82

PRIMARY outcome

Timeframe: 3 months

Population: Only subjects completed 3 M FU were analyzed

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).

Outcome measures

Outcome measures
Measure	Treatment Arm n=12 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Assessment of Adverse Events Occurrence Based on Severity	0 score Standard Deviation 0

PRIMARY outcome

Timeframe: 1 month

Population: Only subjects completed 1 Month FU were analyzed

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).

Outcome measures

Outcome measures
Measure	Treatment Arm n=12 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Assessment of Adverse Events Occurrence Based on Severity	0 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: 1 week

Population: Only subjects completed 1 week FU were analyzed

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).

Outcome measures

Outcome measures
Measure	Treatment Arm n=12 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Assessment of Adverse Events Occurrence Based on Severity	0.08 score on a scale Standard Deviation 0.27

PRIMARY outcome

Timeframe: Treatment Day

Population: All subjects undergone treatment were analyzed

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).

Outcome measures

Outcome measures
Measure	Treatment Arm n=15 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Assessment of Adverse Events Occurrence Based on Severity	0.2 score on a scale Standard Deviation 0.41

PRIMARY outcome

Timeframe: 6 months

Population: Only subjects completed 6 months FU were analyzed

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.

Outcome measures

Outcome measures
Measure	Treatment Arm n=11 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)	0 score Standard Deviation 0

PRIMARY outcome

Timeframe: 6 Months

Population: Only subjects completed 6 M FU were analyzed

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).

Outcome measures

Outcome measures
Measure	Treatment Arm n=11 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Assessment of Adverse Events Occurrence Based on Severity	0 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: 3 months

Population: Only subjects completed 6 months FU were analyzed

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.

Outcome measures

Outcome measures
Measure	Treatment Arm n=12 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)	0 score Standard Deviation 0

PRIMARY outcome

Timeframe: 1 week

Population: Only subjects completed 1 week FU were analyzed

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.

Outcome measures

Outcome measures
Measure	Treatment Arm n=12 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)	0.16 score Standard Deviation 0.55

PRIMARY outcome

Timeframe: Treatment Day

Population: Only subjects completed treatment were analyzed

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.

Outcome measures

Outcome measures
Measure	Treatment Arm n=15 Participants Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)	0.4 score Standard Deviation 0.8

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Arm n=15 participants at risk Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Surgical and medical procedures Pain	26.7% 4/15 • Number of events 4 • Adverse event data was collected over a period of 6 months

Additional Information

Maria Shusterman

InMode

Phone: 855.411.2639

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place