Pivotal Study of the Cabochon System for Improvement in the Appearance of Cellulite
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Merz North America, Inc.
- Enrollment
- 55
- Locations
- 6
- Primary Endpoint
- Mean Change (Decrease) in Cellulite Severity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Mean Change (Decrease) in Cellulite Severity
Time Frame: 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 Outcomes
- Improved Appearance(Treatment to 3 and 5 years)
- Improvement in Cellulite Severity Grade(3 and 5 years)
- Subject Satisfaction(Treatment to 3 and 5 years)
- Procedure Tolerability(Treatment to 3 and 5 years)
- Safe Treatment(Treatment to 3 and 5 years)