Expired Study
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Chicago, Illinois 60611


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.


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.


Study is Available At:


Original ID:

STU34401


NCT ID:

NCT01209767


Secondary ID:


Study Acronym:


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.


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Northwestern University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

22


Enrollment Type:

Actual


Overall Contact Information

Official Name:Murad Alam, MD
Principal Investigator
Northwestern University

Study Dates

Start Date:October 2010
Completion Date:September 2011
Completion Type:Actual
Primary Completion Date:September 2011
Primary Completion Type:Actual
Verification Date:November 2012
Last Changed Date:November 5, 2012
First Received Date:September 24, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Live rating of blinded dermatologists using cellulite severity scale
Time Frame:12 weeks
Safety Issues:False
Description: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. Two dermatologists will blindly evaluate and compare the treated and c
Outcome Type:Secondary Outcome
Measure:Subject satisfaction /Any adverse event from both treatments will be recorded
Time Frame:12weeks
Safety Issues:True
Description:Subject satisfaction will be determined and recorded on the Subject satisfaction questionnaire. 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 disc

Study Interventions

Intervention Type:Procedure
Name:Subcision
Description: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.
Arm Name:subcision
Intervention Type:Device
Name:cryolipolysis
Description: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
Arm Name:cryolipolysis

Study Arms

Study Arm Type:Experimental
Arm Name:cryolipolysis
Study Arm Type:Active Comparator
Arm Name:subcision

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Northwestern University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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