Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cryolipolysis and Subcision for Treatment of Cellulite

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01209767
Recruitment Status : Completed
First Posted : September 27, 2010
Results First Posted : February 3, 2014
Last Update Posted : February 3, 2014
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Tracking Information
First Submitted Date  ICMJE September 24, 2010
First Posted Date  ICMJE September 27, 2010
Results First Submitted Date  ICMJE September 3, 2013
Results First Posted Date  ICMJE February 3, 2014
Last Update Posted Date February 3, 2014
Study Start Date  ICMJE October 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2013)
Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance. [ Time Frame: 12 weeks ]
Two dermatologists blindly evaluated and compared the treated and control areas of each side at the final follow up visit (week 12). They rated the area with the best cosmetic appearance and reported the percentages of participants for whom "Cryolipolysis" or "Subcision" resulted in the "best cosmetic appearance". It was possible for raters to determine that neither treatment outperformed the other, thereby rating the control arm better.
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2010)
Live rating of blinded dermatologists using cellulite severity scale [ Time Frame: 12 weeks ]
  1. Live rating of blinded dermatologists using cellulite severity scale ,the reduction in score on 3-month follow up visit from baseline in at least 1 grade will be consider as improved.
  2. Two dermatologists will blindly evaluate and compare the treated and control areas of each side at the final follow up visit (week 12). They will record the comparisons on the live rating of blinded dermatologist questionnaire.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2010)
Subject satisfaction /Any adverse event from both treatments will be recorded [ Time Frame: 12weeks ]
  1. Subject satisfaction will be determined and recorded on the Subject satisfaction questionnaire.
  2. Subjects will assess and record their discomfort during the procedure using a 10-point visual analog scale provided on the Visual analog scale of subject discomfort during the time of treatment. 3. Any adverse event from both treatments will be recorded on the adverse event record.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cryolipolysis and Subcision for Treatment of Cellulite
Official Title  ICMJE Comparison of the Efficacy Between Cryolipolysis and Subcision for Treatment of Cellulite: A Prospective Randomized Control Trial.
Brief Summary This study intended to investigate and compare the changes that may occur in response to cryolipolysis (localized cool exposure) and subcision (surgical technique) on cellulite. The cryolipolysis cooling device used is FDA approved for skin cooling, but still investigational in the treatment of cellulite. It has previously been used for fat reduction on love handles or back fat. During cryolipolysis, the system drew fat tissue into an applicator then exposes the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite. Subcision is a process used to treat scars left behind by acne or other skin diseases and has been noted to improve moderate to severe cellulite. Subcision is a simple surgical procedure that is performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together. This study was a pilot study designed to determine feasibility of these procedures.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cellulite
Intervention  ICMJE
  • Device: cryolipolysis
    During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
  • Procedure: Subcision
    Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
  • Other: Control
    Other Name: No intervention in this group
Study Arms  ICMJE
  • Experimental: cryolipolysis
    Intervention: Device: cryolipolysis
  • Active Comparator: subcision
    Intervention: Procedure: Subcision
  • Active Comparator: Control
    Areas with cellulite that had no treatment performed were considered the control arm.
    Intervention: Other: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2012)
22
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2010)
15
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy female patients 18-60 years of age with more than one evident depressed lesion of cellulite on the upper thighs and/or buttocks.
  • All subjects must have the affected areas that show the mattress phenomenon spontaneously when standing or while both lying and standing (Stage 2 or 3 of Nurnberger-Muller grading scale of cellulite7).
  • Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion Criteria:

  • Pregnant or lactating
  • Subjects who are unable to understand the protocol or to give informed consent.
  • Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder.
  • Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold urticaria.
  • Subjects who have active skin disease or skin infection in treatment area.
  • Subjects who are allergic to lidocaine or prilocaine.
  • Subjects who are allergic to both cephalexin (and penicillin) AND levofloxacin (or another quinolone antibiotic).
  • Subjects who have history of abnormal scarring.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01209767
Other Study ID Numbers  ICMJE STU34401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Murad Alam, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Murad Alam, MD Northwestern University
PRS Account Northwestern University
Verification Date December 2013

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