Cryolipolysis and Subcision for Treatment of Cellulite - Full Text View

Purpose

This study intends 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 that will be 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 will draw fat tissue into an applicator then expose the extracted fat tissue to cold temperatures. The cold exposure causes 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 is a pilot study designed to determine feasibility of these procedures.

Condition	Intervention
Cellulite	Device: cryolipolysis Procedure: Subcision

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparison of the Efficacy Between Cryolipolysis and Subcision for Treatment of Cellulite: A Prospective Randomized Control Trial.

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Live rating of blinded dermatologists using cellulite severity scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Subject satisfaction /Any adverse event from both treatments will be recorded [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
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.

Enrollment:	22
Study Start Date:	October 2010
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: cryolipolysis	Device: cryolipolysis During cryolipolysis, the system will draw fat tissue into an applicator then expose the extracted fat tissue to cold temperatures. The cold exposure causes fat cells to die, with the goal to decrease the raised areas of cellulite
Active Comparator: subcision	Procedure: Subcision 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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209767

Locations

United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Murad Alam, MD

Northwestern University

More Information

No publications provided

Responsible Party:	Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier:	NCT01209767 History of Changes
Other Study ID Numbers:	STU34401
Study First Received:	September 24, 2010
Last Updated:	November 5, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

Cellulite
Cryolipolysis
Zeltiq
Subcision

ClinicalTrials.gov processed this record on June 18, 2013