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: December 3, 2021
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Murad Alam, Northwestern University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cellulite	Device: cryolipolysis; Procedure: Subcision; Other: Control	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: cryolipolysis	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
Active Comparator: subcision	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.
Active Comparator: Control; Areas with cellulite that had no treatment performed were considered the control arm.	Other: Control; Other Name: No intervention in this group

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery and Surgery-Organ Transplantation, Northwestern University
• ClinicalTrials.gov Identifier: NCT01209767
• Other Study ID Numbers: STU34401
• First Posted: September 27, 2010
• Results First Posted: February 3, 2014
• Last Update Posted: December 3, 2021
• Last Verified: December 2021

Keywords provided by Murad Alam, Northwestern University:

Cellulite; Cryolipolysis; Zeltiq; Subcision

Additional relevant MeSH terms:

Cellulite; Skin Manifestations