Study of the Cabochon System for Improvement in the Appearance of Cellulite

Not Applicable

Completed

Conditions: Gynoid Lipodystrophy

Interventions: Device: Subcutaneous tissue release with the Cabochon System

Registration Number: NCT01671839

Lead Sponsor: Merz North America, Inc.

Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System for the improvement in the appearance of cellulite.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 55

Inclusion Criteria

Female, age 18-55
moderate or severe cellulite
BMI less than 35
will not to try any other cellulite treatments through 12M follow-up

Exclusion Criteria

cellulite treatment on the thighs or buttocks in the last 90 days
prior liposuction in the thighs or buttocks
Greater than 10% increase or decrease in body weight within past 6 months
evidence of active infection or a fever >38C
current or recent smoker
history of hypertension, diabetes or hypoglycemia
history of coagulopathy(ies) and/or on anticoagulant medication
history of cardiopathy or pneumopathy
history of severe anemia
has atrophic scars, or has a history of atrophic scars or keloids
taken within 14 days of treatment:
- NSAIDs (e.g. aspirin, ibuprofen, naproxen)
- Vitamin E, dietary supplements (e.g. Gingko Biloba, willow bark)
- Herbal Teas
Subject is pregnant or lactating

For Extended Follow-Up the following apply:

Inclusion Criteria:

Subject was enrolled and treated in the CP-01-1004 study - Pivotal Study of the Cabochon System for Improvement in the Appearance of Cellulite
Subject understands and accepts the obligation not to try or receive any other cellulite treatments through 3 year follow-up

Exclusion Criteria:

Subject has undergone an injected drug, energy-based device, minimally-invasive or invasive procedure for contouring or cellulite on the buttocks or thighs since their 12 month study follow-up visit.
Subject has used skin care products (e.g. creams) for improvement in cellulite within 1 month prior to the follow-up visit.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subcutaneous tissue release	Subcutaneous tissue release with the Cabochon System	Device: Subcutaneous tissue release with the Cabochon System

Primary Outcome Measures

Name	Time	Method
Mean Change (Decrease) in Cellulite Severity	Treatment to 3 and 5 years	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.

Secondary Outcome Measures

Name	Time	Method
Improved Appearance	Treatment to 3 and 5 years	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
Improvement in Cellulite Severity Grade	3 and 5 years	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.
Subject Satisfaction	Treatment to 3 and 5 years	Subject rated satisfaction according to a 5 point Likert scale after treatment: Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied
Procedure Tolerability	Treatment to 3 and 5 years	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
Safe Treatment	Treatment to 3 and 5 years	Freedom from serious adverse events directly attributable to the Cabochon System or procedure.

Trial Locations

Locations (3): Maryland Laser Skin & Vein Institute
🇺🇸
Hunt Valley, Maryland, United States
The Coleman Center for Cosmetic and Dermatologic Surgery
🇺🇸
Metairie, Louisiana, United States
SkinCare Physicians
🇺🇸
Chestnut Hill, Massachusetts, United States