Clinical Study to Evaluate the Performance of the Profound System for the Treatment of Cellulite.
Up to 60 healthy female volunteers, seeking cellulite treatment, 18 to 60 years of age from up to 3 investigational sites. Prospective, open-label, baseline-controlled, two arms, randomized, clinical study to evaluate the Profound device using the Dermal and SubQ Cartridges for minimally-invasive treatment of the upper thighs and buttocks cellulite appearance. The treatment areas of the study subjects will be divided into two arms: 1. Arm 1 - the upper thigh/buttock on the left or right side of the body will undergo a single Profound treatment utilizing the Dermal and SubQ Cartridges 2. Arm 2 - the contralateral upper thigh/buttock side of the body will undergo a single Profound treatment utilizing the SubQ Cartridge only. Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
The main intent of the Profound Dermal and Subdermal cartridges for cellulite treatment is to utilize a minimally-invasive approach to directly deliver radiofrequency (RF) energy into tissue through pairs of micro-electrode needles and use temperature sensors within the needles to reliably create fractional thermal injuries within the skin.
Macrene Alexiades
New York, New York, United States
Girish Munavalli
Charlotte, North Carolina, United States
Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations
Evaluate the improvement in global aesthetic appearance of cellulite in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1,3 and 6 months post treatment visit. Investigators used the following scale: 0=No Change; 1= 1-24% improvement; 2=25-49% improvement; 3=50-74% improvement; 4=75-100% improvement. The analysis calculates the improvement over 25% (grades 2-4)
Time frame: 1,3 and 6 months post-treatment
Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations
Evaluate the improvement in skin tightening in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1 and 6 months post treatment visit. Investigators used the following scale: (0) No tightening/firmness; (1) Slightly visible tightening/firmness; (2) Visible tightening/firmness; (3) Very visible tightening/firmness. The analysis calculates the skin tightening improvement graded: (2) Visible tightening/firmness and (3) Very visible tightening/firmness
Time frame: 1, 3 and 6 months post treatment visit.
Investigator Satisfaction - by Questionnaire
Evaluate Investigator satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale \[(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied\]. The analysis quantify investigator satisfaction (grades 1-2)
Time frame: 1, 3, and 6 months post-treatment visit
Subject Satisfaction and Improvement - by Questionnaire
Evaluate subject satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction and improvement scale \[(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied\]. The analysis quantify subject satisfaction (grades 1-2)
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Time frame: 1, 3, and 6 months post-treatment visit