Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite

Not Applicable

Active, not recruiting

• Conditions: Cellulite
• Interventions: Procedure: cyrolipolysis (CoolSculpting device); Procedure: subcision

• Registration Number: NCT02427698
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-22
• Study First Posted: 2015-04-28
• Study Start: 2015-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

1. Healthy female subjects 18-65 years of age with at least a 5 on the CSS scale on both outer thighs.
2. 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).
3. 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.

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Exclusion Criteria

1. Subjects who are pregnant or lactating.
2. Subjects who are unable to understand the protocol or to give informed consent.
3. Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder.
4. Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobulinuria, cold urticaria.
5. Subjects who have active skin disease or skin infection in the treatment area.
6. Subjects who are allergic to lidocaine or prilocaine.
7. Subjects who are allergic to both cephalexin (or penicillin) AND levofloxacin (or another quinolone antibiotic).
8. Subjects who have history of abnormal scarring.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cyrolipolysis	cyrolipolysis (CoolSculpting device)	-
cryolipolysis plus subcision	cyrolipolysis (CoolSculpting device)	-
cryolipolysis plus subcision	subcision	-

Primary Outcome Measures

Name	Time	Method
Live rating by a blinded dermatologist using cellulite severity scale	Change from Baseline in cellulite severity scale at 3 months	The cellulite severity scale rates cellulite 1-5 as mild, 6-10 as moderate, and 11-15 as severe.

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology; 🇺🇸 Chicago, Illinois, United States