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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cabochon Aesthetics, Inc.
ClinicalTrials.gov Identifier:
NCT01671839
First received: August 17, 2012
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System for the improvement in the appearance of cellulite.


Condition Intervention
Gynoid Lipodystrophy
Device: Subcutaneous tissue release with the Cabochon System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pivotal Study of the Cabochon System for Improvement in the Appearance of Cellulite

Resource links provided by NLM:


Further study details as provided by Cabochon Aesthetics, Inc.:

Primary Outcome Measures:
  • Mean Change in Cellulite Severity [ Time Frame: Treatment to 1 year ] [ Designated as safety issue: No ]
    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 1 year 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 1 year after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 1-year for the study population which was a minimum of 1 point lower than the baseline severity. Paired t-test test with a critical 1-sided alpha level of 0.025 was carried out on the mean Cellulite Severity Scale (0-5) change between 1 year and baseline visits.


Secondary Outcome Measures:
  • Improvement in Cellulite Severity Grade [ Time Frame: 1-year ] [ Designated as safety issue: No ]
    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 1 year after treatment.

  • Improved Appearance [ Time Frame: Treatment to 1 year ] [ Designated as safety issue: No ]

    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 1 year 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 [ Time Frame: Treatment to 1 year ] [ Designated as safety issue: No ]

    Subject rated satisfaction according to a 5 point Likert scale after treatment:

    Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied


  • Procedure Tolerability [ Time Frame: Treatment to 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment to 1 year ] [ Designated as safety issue: Yes ]
    Freedom from serious adverse events directly attributable to the Cabochon System or procedure.


Enrollment: 55
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subcutaneous tissue release
Device: Subcutaneous tissue release with the Cabochon System
Device: Subcutaneous tissue release with the Cabochon System
Device: Subcutaneous tissue release

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671839

Locations
United States, Louisiana
The Coleman Center for Cosmetic and Dermatologic Surgery
Metairie, Louisiana, United States, 70006
United States, Maryland
Maryland Laser Skin & Vein Institute
Hunt Valley, Maryland, United States, 21030
United States, Massachusetts
SkinCare Physicians
Chestnut Hill,, Massachusetts, United States, 02467
Sponsors and Collaborators
Cabochon Aesthetics, Inc.
Investigators
Principal Investigator: Michael S Kaminer Skin Care Physicians
  More Information

No publications provided

Responsible Party: Cabochon Aesthetics, Inc.
ClinicalTrials.gov Identifier: NCT01671839     History of Changes
Other Study ID Numbers: CP-01-1004
Study First Received: August 17, 2012
Results First Received: July 25, 2014
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lipodystrophy
Lipid Metabolism Disorders
Metabolic Diseases
Skin Diseases
Skin Diseases, Metabolic

ClinicalTrials.gov processed this record on October 23, 2014