search
Back to results

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

Primary Purpose

Gynoid Lipodystrophy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Subcutaneous tissue release with the Cabochon System
Sponsored by
Merz North America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynoid Lipodystrophy

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • The Coleman Center for Cosmetic and Dermatologic Surgery
  • Maryland Laser Skin & Vein Institute
  • SkinCare Physicians

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subcutaneous tissue release

Arm Description

Device: Subcutaneous tissue release with the Cabochon System

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Subject Satisfaction
Subject rated satisfaction according to a 5 point Likert scale after treatment: Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied
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
Safe Treatment
Freedom from serious adverse events directly attributable to the Cabochon System or procedure.

Full Information

First Posted
August 17, 2012
Last Updated
November 22, 2019
Sponsor
Merz North America, Inc.
Collaborators
Ulthera, Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT01671839
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz North America, Inc.
Collaborators
Ulthera, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynoid Lipodystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subcutaneous tissue release
Arm Type
Experimental
Arm Description
Device: Subcutaneous tissue release with the Cabochon System
Intervention Type
Device
Intervention Name(s)
Subcutaneous tissue release with the Cabochon System
Other Intervention Name(s)
Cellfina®
Intervention Description
Device: Subcutaneous tissue release
Primary Outcome Measure Information:
Title
Mean Change (Decrease) in Cellulite Severity
Description
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.
Time Frame
Treatment to 3 and 5 years
Secondary Outcome Measure Information:
Title
Improvement in Cellulite Severity Grade
Description
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.
Time Frame
3 and 5 years
Title
Improved Appearance
Description
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
Time Frame
Treatment to 3 and 5 years
Title
Subject Satisfaction
Description
Subject rated satisfaction according to a 5 point Likert scale after treatment: Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied
Time Frame
Treatment to 3 and 5 years
Title
Procedure Tolerability
Description
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
Time Frame
Treatment to 3 and 5 years
Title
Safe Treatment
Description
Freedom from serious adverse events directly attributable to the Cabochon System or procedure.
Time Frame
Treatment to 3 and 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Kaminer
Organizational Affiliation
Skin Care Physicians
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Coleman Center for Cosmetic and Dermatologic Surgery
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Maryland Laser Skin & Vein Institute
City
Hunt Valley
State/Province
Maryland
ZIP/Postal Code
21030
Country
United States
Facility Name
SkinCare Physicians
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs