Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite

Cellulite Clinical Trial

Official title:

Comparison of the Efficacy Between Cryolipolysis Versus Cryolipolysis Plus Subcision For Treatment of Cellulite: A Prospective Randomized Control Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02427698
• Other study ID #: STU200346
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Cellulite

Intervention

Procedure:
• cyrolipolysis (CoolSculpting device)
Treatment will be a cold exposure for up to 120 minutes using the CoolSculpting device with a commercially available treatment setting.
• subcision
The skin will be punctured using a subcision needle to cut the septa responsible for the skin depression after cryolipolysis.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Zeltiq Aesthetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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