N/A
N=55
Study of the Cabochon System for Improvement in the Appearance of Cellulite
Gynoid Lipodystrophy
Bottom Line
View on ClinicalTrials.gov: NCT01671839 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Mean Change (Decrease) in Cellulite Severity — 2.0; 1.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Subcutaneous tissue release with the Cabochon System (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merz North America, Inc.
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change (Decrease) in Cellulite Severity |
2.0; 1.8 | — |
| SECONDARY Improvement in Cellulite Severity Grade |
91.1; 86 | — |
| SECONDARY Improved Appearance |
8.9; 5.4; 46.7; 29.7; 44.4; 64.9 | — |
| SECONDARY Subject Satisfaction |
42.2; 46.0; 51.1; 32.4; 6.7; 18.9 | — |
| SECONDARY Procedure Tolerability |
0; 0 | — |
| SECONDARY Safe Treatment |
0; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01671839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.