Cryolipolysis and Subcision for Treatment of Cellulite
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|ClinicalTrials.gov Identifier: NCT01209767|
Recruitment Status : Completed
First Posted : September 27, 2010
Results First Posted : February 3, 2014
Last Update Posted : February 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cellulite||Device: cryolipolysis Procedure: Subcision Other: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of the Efficacy Between Cryolipolysis and Subcision for Treatment of Cellulite: A Prospective Randomized Control Trial.|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
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
|Active Comparator: 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.
Active Comparator: Control
Areas with cellulite that had no treatment performed were considered the control arm.
Other Name: No intervention in this group
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209767
|United States, Illinois|
|Northwestern University Feinberg School of Medicine, Department of Dermatology|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Murad Alam, MD||Northwestern University|