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

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

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 Overview

• Status: Completed
• Conditions: Gynoid Lipodystrophy
• Intervention / Treatment: Device: Subcutaneous tissue release with the Cabochon System

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • The Coleman Center for Cosmetic and Dermatologic Surgery
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • Maryland Laser Skin & Vein Institute
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Skincare Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subcutaneous tissue release; Device: Subcutaneous tissue release with the Cabochon System	Device: Subcutaneous tissue release with the Cabochon System; Device: Subcutaneous tissue release; Other Names: Cellfina®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Treatment to 3 and 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	Treatment to 3 and 5 years
Safe Treatment	Freedom from serious adverse events directly attributable to the Cabochon System or procedure.	Treatment to 3 and 5 years

Collaborators and Investigators

• Sponsor: Merz North America, Inc.
• Collaborators: Ulthera, Inc
• Investigators: Principal Investigator: Michael S Kaminer, Skin Care Physicians

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 17, 2012
• First Submitted That Met QC Criteria: August 21, 2012
• First Posted (Estimate): August 24, 2012

Study Record Updates

• Last Update Posted (Actual): December 10, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Skin Diseases; Lipid Metabolism Disorders; Skin Manifestations; Skin Diseases, Metabolic; Cellulite; Lipodystrophy
• Other Study ID Numbers: CP-01-1004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No