Clinical Evaluation of CelluTite Treatment
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|ClinicalTrials.gov Identifier: NCT03769649|
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : February 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cellulite of Thighs||Device: CelluTite||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Subjects will receive the treatment and outcome will be followed|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of Safety and Efficacy of the CelluTite Treatment|
|Actual Study Start Date :||November 12, 2018|
|Actual Primary Completion Date :||January 17, 2020|
|Actual Study Completion Date :||January 17, 2020|
Experimental: Treatment arm
Subjects receive CelluTite treatment followed by Morpheus8 treatment
CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Other Name: Morpheus8
- Reduction in cellulite score rated according to Cellulite severity scale at follow- up visits comparing to baseline score. [ Time Frame: 7 months ]
Photos from all time points (baseline and follow-up visits) will be evaluated by the treating physician and 2 independent evaluators.
Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). This 5-point photonumeric scale rates cellulite severity from a score "0" (none) to "4" (severe) from a clinician's perspective in two main clinical morphologic features of cellulite (categories): (A) number of evident dimples; and (B) severity of linear undulations. Cellulite score is a given based on a combination of the two characteristics: number of dimples and severity of modulations. Score reduction at follow-up visit comparing to baseline indicates that treatment is effective.
- Occurrence of adverse events will be assessed based on frequency, severity and causality data. [ Time Frame: 7 months ]Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done immediately after treatments and at all follow-up visits. Each occurrence will be described in a table presenting data including severity (mild, moderate or severe), causality (relationship to the device or the treatment), treatment and resolution. Data will be summarized and adverse event significance will be considered based on combination of the above listed items.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769649
|United States, New York|
|New York, New York, United States, 10022|
|Principal Investigator:||Bruce Katz, MD||60 E 56th St #2, New York, NY 10022, USA|