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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two treatments for cellulite on the outer thighs. One treatment uses cryolipolysis, which cools fat to break it down. The other combines cryolipolysis with surgical subcision, a procedure that cuts the fibrous bands under the skin. Women with noticeable cellulite on their outer thighs, visible when standing or lying down, may be suitable candidates for this study. Participants will assist researchers in determining which treatment more effectively reduces cellulite. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new cellulite treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cryolipolysis, a treatment that reduces fat by freezing it, is generally safe. Studies indicate a low rate of side effects, with only about 2% of treatment sessions resulting in mild and treatable negative effects. Most people who have tried cryolipolysis report high satisfaction with the results, and it is safe for all skin types.

Less specific safety information exists about combining cryolipolysis with subcision, a minor procedure that cuts fibrous bands under the skin. However, cryolipolysis alone is well-tolerated, and subcision has been safely used in other treatments. This suggests the combination might also be safe, though combining treatments could introduce new risks. It is important to consult healthcare providers to understand the potential benefits and risks before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining cryolipolysis and subcision for cellulite because this approach targets the problem in two innovative ways. Cryolipolysis is a non-invasive treatment that freezes fat cells, helping to smooth out the skin's surface. Subcision, on the other hand, involves using a needle to break up the fibrous bands beneath the skin that contribute to the dimpled appearance. Unlike standard treatments like topical creams or laser therapy, this dual approach addresses both fat reduction and the structural causes of cellulite, potentially offering more comprehensive and longer-lasting results.

What evidence suggests that this trial's treatments could be effective for cellulite?

Research has shown that cryolipolysis, a treatment that freezes fat cells to reduce fat, yields promising results. One study found that patients experienced an average fat reduction of 28.5% in treated areas. Cryolipolysis can also improve skin texture and reduce the appearance of cellulite. In this trial, some participants will receive cryolipolysis alone, while others will receive a combination of cryolipolysis and subcision, a simple procedure that breaks up bands under the skin. Although specific data on combining both treatments isn't detailed here, the combination is believed to target cellulite more effectively by enhancing both fat reduction and skin texture. ^{1 4 6 7 8}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: cryolipolysis plus subcision Active Control 2 Interventions

Group II: cyrolipolysis Active Control 1 Intervention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Zeltiq Aesthetics

Industry Sponsor

Trials

41

Recruited

1,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4444424/

Cryolipolysis for Fat Reduction and Body Contouring In one study, patients receiving two treatments in the peritrochanteric area yielded an average fat layer reduction of 28.5 percent, compared ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/jocd.16039

Cryolipolysis: A promising nonsurgical technique for ... They demonstrated that 6 months after their treatment, the mean abdominal fat layer thickness reduction was 46.6%, and measured mean contour was ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5236497/

Review of the Mechanisms and Effects of Noninvasive Body ... Skin texture, laxity and cellulite were improved after the treatment (42). The long-term effect was not clear. In two case reports, it was mentioned that two ...

4. journals.lww.com journals.lww.com/dermatologicsurgery/fulltext/2025/06000/safety,_effectiveness,_and_participant.9.aspx

Safety, Effectiveness, and Participant Satisfaction With... Studies identified in a systematic literature review cited a mean 0.2- to 0.51-cm reduction in fat layer thickness, depending on the body area treated. ...

5. dovepress.com dovepress.com/quantitative-assessment-of-the-cryolipolysis-method-for-body-contourin-peer-reviewed-fulltext-article-CCID

Cryolipolysis Method for Body Contouring | CCID There was a significant reduction in the circumference of both the abdomen and upper arm areas (P < 0.05). Additionally, 16.7% and 18.5% of ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/jocd.16029

Cryolipolysis in the United States—Review of the clinical data Cryolipolysis is a safe, modestly effective method for reducing focal adiposity. Complications are rare and treatable. However, US-based studies are few in ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39829238/

Evaluating Real-world Use and Adverse Events From 3262 ... Eighty-seven patients exhibited 180 adverse events (2.05% of cycles), including 3 body areas (n = 2) with paradoxical adipose hyperplasia.

8. thepmfajournal.com thepmfajournal.com/features/post/cryolipolysis-a-review-of-published-clinical-data

Cryolipolysis: a review of published clinical data Cryolipolysis is safe for all skin types, with no reported pigmentary changes, and is safe for repeated application [15]. Ferraro et al. suggest that patients ...