The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System for the improvement in the appearance of cellulite.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Device: Subcutaneous tissue release
The Coleman Center for Cosmetic and Dermatologic Surgery
Metairie, Louisiana, United States
Maryland Laser Skin & Vein Institute
Hunt Valley, Maryland, United States
SkinCare Physicians
Chestnut Hill, Massachusetts, United States
Mean Change (Decrease) in Cellulite Severity
Achievement of ≥1 point mean reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 3 and 5 years after treatment. Cellulite severity was graded on a 0 (no cellulite) to 5 (severe cellulite) for each subject photograph taken at baseline (before treatment) and 3 and 5 years after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 3 and 5 years for the study population which was a minimum of 1 point lower than the baseline severity.
Time frame: Treatment to 3 and 5 years
Improvement in Cellulite Severity Grade
Percentage of subjects which were scored to have improvement of one grade or more in a 4 point Severity Grade (none, mild, moderate, severe) as determined by independent blinded physician assessment of subject photographs taken before and 3 and 5 years after treatment.
Time frame: 3 and 5 years
Improved Appearance
Improvement in subject's cellulite appearance according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent and blinded physician panel assessment of subject photographs taken before and 3 and 5 years after treatment. Change in the cellulite severity was rated according to 5 measures: * Very much improved: Optimal cosmetic result in the treated areas for this subject * Much improved: Marked or significant improvement in appearance of the treated areas from the initial condition * Improved: Noticeable improvement in appearance of the treated areas from the initial condition but more subtle in magnitude * No Change: The appearance of the treated areas is essentially the same as the original condition * Worse: The appearance of the treated areas is worse than the original condition
Time frame: Treatment to 3 and 5 years
Subject Satisfaction
Subject rated satisfaction according to a 5 point Likert scale after treatment: Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied
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Time frame: Treatment to 3 and 5 years
Procedure Tolerability
Subject rated pain according to a 0-10 numerical rating scale. Pain scale ranges from 0 (no pain) to 10 (worst possible pain). Measure was reported as mean and standard deviation of the pain score
Time frame: Treatment to 3 and 5 years
Safe Treatment
Freedom from serious adverse events directly attributable to the Cabochon System or procedure.
Time frame: Treatment to 3 and 5 years