Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite

NCT02427698 | Active Not Recruiting DMC

• 1 other identifier: STU200346
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized controlled study comparing the efficacy of cryolipolysis versus a combination of cryolipolysis and surgical subcision for the treatment of cellulite. The treatment sites are both outer thighs. One outer thigh will be randomized to receive one treatment of cryolipolysis, while the contralateral thigh will be assigned to receive the combination cryolipolysis plus surgical subcision. A live rating by a blinded dermatologist will evaluate the treatment and control areas using a cellulite severity scale at week 0 (before treatment) and at the 3-month follow up visit.

Conditions

Cellulite

Outcome Measures

Primary Outcomes (1)

• Live rating by a blinded dermatologist using cellulite severity scale

  The cellulite severity scale rates cellulite 1-5 as mild, 6-10 as moderate, and 11-15 as severe.

  Change from Baseline in cellulite severity scale at 3 months

Study Arms (2)

cyrolipolysis

ACTIVE COMPARATOR

Procedure: cyrolipolysis (CoolSculpting device)

cryolipolysis plus subcision

ACTIVE COMPARATOR

Procedure: cyrolipolysis (CoolSculpting device); Procedure: subcision

Interventions

cyrolipolysis (CoolSculpting device) PROCEDURE

Treatment will be a cold exposure for up to 120 minutes using the CoolSculpting device with a commercially available treatment setting.

cryolipolysis plus subcision; cyrolipolysis

subcision PROCEDURE

The skin will be punctured using a subcision needle to cut the septa responsible for the skin depression after cryolipolysis.

cryolipolysis plus subcision

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female subjects 18-65 years of age with at least a 5 on the CSS scale on both outer thighs.
• 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.

You may not qualify if:

• Subjects who are 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 hemoglobulinuria, cold urticaria.
• Subjects who have active skin disease or skin infection in the treatment area.
• Subjects who are allergic to lidocaine or prilocaine.
• Subjects who are allergic to both cephalexin (or penicillin) AND levofloxacin (or another quinolone antibiotic).
• Subjects who have history of abnormal scarring.

Sponsors & Collaborators

• Northwestern University: lead
• Zeltiq Aesthetics: collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 28, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (1)