Thigh Circumference Reduction Study

This study has been terminated.
(The study was terminated because the preliminary data did not indicate efficacy.)
Sponsor:
Information provided by:
Cutera Inc.
ClinicalTrials.gov Identifier:
NCT00953290
First received: August 4, 2009
Last updated: May 6, 2011
Last verified: May 2011
  Purpose

The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference.


Condition Intervention
Reduction of Localized Excess Fat
Device: Cutera Radio Frequency Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cutera Radio Frequency Device for Thigh Circumference Reduction

Further study details as provided by Cutera Inc.:

Primary Outcome Measures:
  • Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms [ Time Frame: Baseline and 6 months post final treatment ] [ Designated as safety issue: No ]
    Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]

  • Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms [ Time Frame: Baseline and 6 months post final treatment ] [ Designated as safety issue: No ]
    Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]


Secondary Outcome Measures:
  • Subject Satisfaction [ Time Frame: Baseline and 6 months post final treatment ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: At each visit (treatment and follow-up) or until resolution of AEs ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: January 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treated Thigh
The thigh treated with the RF device
Device: Cutera Radio Frequency Device
Up to three treatments, one pass, dosage range of 15-60 kJ.
Other Name: Callisto, TruForm, TruSculpt
No Intervention: Untreated Thigh
The untreated thigh

Detailed Description:

The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction of thigh circumference.

At investigator's discretion, each subject will receive up to three treatments on one thigh and will be scheduled for two follow-up visits after the final treatment. The treated thigh will be clinically evaluated for side effects and both treated and untreated control thigh will be measured and photographed at each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body Mass Index between 20 and 35
  • Presence of cellulite grades II, III or IV according to GLD scale
  • Visible bi-lateral thigh fat Thigh area to be treated to measure at least 30.0mm in vertical fold, as measured with industry standard fat caliper
  • Subject must be able to read, understand and sign the Consent Form
  • Subject must adhere to the follow-up schedule and study instructions
  • Subject must adhere to the same diet and/or exercise routine throughout the study

Exclusion Criteria:

  • Significant weight fluctuation (+/-10 lbs) in the past 6 months
  • Taking weight-loss medications/supplements
  • Participation in any other clinical study
  • Cellulite treatment within 3 months of the treatment
  • Surgical or non-surgical treatments to the target area in the last 12 months, e.g., liposuction
  • Prior treatment to the target area within the last 12 months
  • Arteriosclerosis or weakened blood vessels
  • Heart disease
  • Thromboembolic disease
  • Diagnosed or documented immune system disorders
  • Bleeding disorders.
  • Presence of uncontrolled hypertension
  • Taking prescription anticoagulants
  • History of keloid formation
  • Malignant tumors in the target area
  • Diabetes
  • Any disease or condition that could impair wound healing
  • Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars
  • Infection in the target area
  • Implanted electrical device(s)
  • 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: NCT00953290

Locations
United States, California
Blackhawk Plastic Surgery
Danville, California, United States, 94506
Sponsors and Collaborators
Cutera Inc.
Investigators
Principal Investigator: Stephen J. Ronan, MD
Principal Investigator: Jacqueline Calkin, MD
Principal Investigator: Christine Lee, MD
Principal Investigator: Scott Kramer, MD
  More Information

No publications provided

Responsible Party: Stephanie Buech, Director of Clinical Research, Cutera Inc.
ClinicalTrials.gov Identifier: NCT00953290     History of Changes
Other Study ID Numbers: CTCS002
Study First Received: August 4, 2009
Results First Received: February 17, 2011
Last Updated: May 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Cutera Inc.:
Cellulite
Adipose tissue
Circumference
Reduction
Thigh

ClinicalTrials.gov processed this record on September 16, 2014