Clinical trial NCT01671839: Study of the Cabochon System for Improvement in the Appearance of Cellulite
Official title: Pivotal Study of the Cabochon System for Improvement in the Appearance of Cellulite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynoid Lipodystrophy
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Ulthera, Inc
First posted: 2012-08-24
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Change (Decrease) in Cellulite Severity
timeFrame: Treatment to 3 and 5 years
Secondary outcomes:
measure: Improvement in Cellulite Severity Grade
timeFrame: 3 and 5 years
measure: Improved Appearance
timeFrame: Treatment to 3 and 5 years
measure: Subject Satisfaction
timeFrame: Treatment to 3 and 5 years
measure: Procedure Tolerability
timeFrame: Treatment to 3 and 5 years
measure: Safe Treatment
timeFrame: Treatment to 3 and 5 years
Other outcomes:
Locations:
city: Metairie
country: United States
facility: The Coleman Center for Cosmetic and Dermatologic Surgery
state: Louisiana
city: Hunt Valley
country: United States
facility: Maryland Laser Skin & Vein Institute
state: Maryland
city: Chestnut Hill
country: United States
facility: SkinCare Physicians
state: Massachusetts
Study officials:
affiliation: Skin Care Physicians
name: Michael S Kaminer
role: PRINCIPAL_INVESTIGATOR
References: