Cyrolipolysis + Subcision for Cellulite

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Pregnancy, Cold-induced disease, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

If you are currently taking antiplatelet or anticoagulant medications, you will need to stop as they are not allowed in this trial. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

What data supports the effectiveness of the treatment Cyrolipolysis + Subcision for Cellulite?

Research shows that cryolipolysis is effective in reducing fat layers and improving body contouring, while subcision is useful for treating advanced cellulite. Combining these treatments may enhance their effectiveness in addressing cellulite by targeting both fat reduction and skin texture improvement.¹ ² ³ ⁴ ⁵

Is the combination of Cryolipolysis and Subcision safe for treating cellulite?

Cryolipolysis is generally considered safe, but it can have side effects like skin changes, frostbite, and rare cases of increased fat in treated areas. Temporary side effects usually resolve on their own. There is no specific safety data on combining Cryolipolysis with Subcision for cellulite.¹ ⁶ ⁷ ⁸ ⁹

How does the treatment of Cryolipolysis + Subcision for cellulite differ from other treatments?

This treatment is unique because it combines cryolipolysis, which uses controlled cooling to reduce fat cells, with subcision, a technique that releases fibrous bands under the skin to improve the appearance of cellulite. This combination targets both fat reduction and the structural causes of cellulite, offering a dual approach that is different from other non-invasive body contouring methods.¹ ⁵ ¹⁰ ¹¹ ¹²

What is the purpose of this trial?

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.

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

Healthy women aged 18-65 with noticeable cellulite on both thighs, who can give informed consent. Excluded are those pregnant or breastfeeding, allergic to certain antibiotics or local anesthetics, taking blood thinners, have a coagulation disorder, abnormal scarring history, active skin disease/infection in the area, or cold-induced diseases.

Inclusion Criteria

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

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)

Exclusion Criteria

Subjects who are pregnant or lactating

Subjects who are unable to understand the protocol or to give informed consent

Subjects who are allergic to both cephalexin (or penicillin) AND levofloxacin (or another quinolone antibiotic)

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cryolipolysis or a combination of cryolipolysis and surgical subcision on the outer thighs

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in cellulite severity using a live rating by a blinded dermatologist

3 months

1 visit (in-person) at 3 months

Treatment Details

Interventions

Cryolipolysis
Subcision

Trial Overview The study is testing if cryolipolysis alone or combined with surgical subcision is more effective for treating cellulite. Each participant's one thigh gets cryolipolysis and the other thigh also gets subcision. A dermatologist will rate cellulite severity before treatment and after three months without knowing which thigh received which treatment.

Participant Groups

2Treatment groups

Active Control

Group I: cryolipolysis plus subcisionActive Control2 Interventions

Group II: cyrolipolysisActive Control1 Intervention