Cryolipolysis and Subcision for Treatment of Cellulite

• 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: Northwestern University
• Information provided by (Responsible Party): Murad Alam, Northwestern University

Tracking Information

• First Submitted Date: September 24, 2010
• First Posted Date: September 27, 2010
• Results First Submitted Date: September 3, 2013
• Results First Posted Date: February 3, 2014
• Last Update Posted Date: February 3, 2014
• Study Start Date: October 2010
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (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: Cryolipolysis and Subcision for Treatment of Cellulite
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Cellulite

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 27, 2012): 22
• Original Estimated Enrollment (submitted: September 24, 2010): 15
• Actual Study Completion Date: September 2011
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01209767
• Other Study ID Numbers: STU34401
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Murad Alam, Northwestern University
• Study Sponsor: Northwestern University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Murad Alam, MD; Northwestern University

• PRS Account: Northwestern University
• Verification Date: December 2013