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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: September 3, 2014
Last verified: September 2014

August 17, 2012
September 3, 2014
August 2012
September 2013   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01671839 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gynoid Lipodystrophy
Device: Subcutaneous tissue release with the Cabochon System
Device: Subcutaneous tissue release
Experimental: Subcutaneous tissue release
Device: Subcutaneous tissue release with the Cabochon System
Intervention: Device: Subcutaneous tissue release with the Cabochon System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
55
December 2015
September 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01671839
CP-01-1004
Yes
Cabochon Aesthetics, Inc.
Cabochon Aesthetics, Inc.
Not Provided
Principal Investigator: Michael S Kaminer Skin Care Physicians
Cabochon Aesthetics, Inc.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP