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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: October 10, 2012
Last verified: October 2012
History of Changes
  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

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

Primary Outcome Measures:
  • Change in cellulite severity [ Time Frame: Treatment to 1 year ] [ Designated as safety issue: No ]
    Change in cellulite severity as determined in an independent physician assessment of subject photographs taken before and after treatment.


Secondary Outcome Measures:
  • 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.

  • Improved Appearance [ Time Frame: Treatment to 1 year ] [ Designated as safety issue: No ]
    Independent physician assessment of subject photographs taken before and after treatment according to Global Aesthetic Improvement Scale.

  • 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.

  • Procedure Tolerability [ Time Frame: Treatment to 1 year ] [ Designated as safety issue: No ]
    Subject rated pain according to a 0-10 numerical rating scale.


Estimated Enrollment: 55
Study Start Date: August 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 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
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
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013