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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Cellulite
Interventions Device: cryolipolysis
Procedure: Subcision
Other: Control
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Subjects Receiving Split Body Treatment
Hide Arm/Group Description

The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision.

cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and 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

Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was 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.

Period Title: Overall Study
Started 22
Completed 18
Not Completed 4
Reason Not Completed
Withdrawal by Subject             1
Lost to Follow-up             3
Arm/Group Title Subjects Receiving Split Body Treatment
Hide Arm/Group Description

The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision.

cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and 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

Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was 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.

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
22
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
39.4  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
22
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
1.Primary Outcome
Title Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance.
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cryolipolysis Subcision Control
Hide Arm/Group Description:
cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and 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
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.
Area that received no treatment
Overall Number of Participants Analyzed 18 18 18
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
22.22
(6.41 to 47.64)
33.33
(13.34 to 59.01)
44.44
(21.53 to 69.24)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cryolipolysis Subcision Control
Hide Arm/Group Description 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 Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was 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. Nothing was done to the area.
All-Cause Mortality
Cryolipolysis Subcision Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Cryolipolysis Subcision Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/22 (0.00%)      0/22 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Cryolipolysis Subcision Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      3/22 (13.64%)      0/22 (0.00%)    
General disorders       
small ulcer  0/22 (0.00%)  0 1/22 (4.55%)  1 0/22 (0.00%)  0
lumps  0/22 (0.00%)  0 2/22 (9.09%)  0/22 (0.00%)  0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Murad Alam
Organization: Northwestern University
Phone: 312-695-4761
EMail: m-alam@northwestern.edu
Layout table for additonal information
Responsible Party: Murad Alam, Northwestern University
ClinicalTrials.gov Identifier: NCT01209767    
Other Study ID Numbers: STU34401
First Submitted: September 24, 2010
First Posted: September 27, 2010
Results First Submitted: September 3, 2013
Results First Posted: February 3, 2014
Last Update Posted: February 3, 2014