Cooled Sodium Chloride for Lipoma

Overseen By Jessica Patterson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: West Virginia University

Disqualifiers: Facial lipomas, Deep tissue lipomas, Large lipomas, Rapid growth, Abnormal ultrasound, Pregnancy

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Lipomas are benign tumors composed of mature adipose tissue. While harmless, these are the most common type of soft tissue growths with some patients developing numerous lipomas. Patients often seek removal for cosmesis, or symptoms caused by location and/or compression of surrounding structures. This exploratory study aims to evaluate the effectiveness of subcutaneous injections of cooled normal saline as a treatment option for lipomas. The study will assess whether this technique could serve as a viable alternative to existing treatment options, especially compared to topically applied fat-freezing devices. The Investigators propose that this method may offer a more comfortable nonsurgical option for targeted fat reduction, as the cold temperatures are applied directly to the lipomas.

Research Team

Jessica Patterson, MD

Principal Investigator

West Virginia University-Dermatology

Eligibility Criteria

This trial is for individuals with benign tumors called lipomas or atypical lipomatous tumors. The study seeks participants who want a non-surgical treatment option, possibly due to cosmetic reasons or discomfort from the tumor's location.

Inclusion Criteria

I have at least one lipoma under my skin.

Exclusion Criteria

I have a lipoma on my face.

My lipoma is located deep within my muscles or under the fascia.

Lipomas exhibiting abnormal ultrasound findings (e.g., complex hyperechoic patterns, internal heterogeneity, or multilobulated appearance)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injections of cooled sodium chloride for lipoma treatment

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cooled Sodium Chloride Injection

Trial Overview The trial is testing subcutaneous injections of cooled sodium chloride as a potential treatment for lipomas. It aims to see if this method can reduce fat in targeted areas more comfortably than current treatments like fat-freezing devices.

Participant Groups

Group I: Cooled Sodium Chloride Injection Experimental Treatment 1 Intervention

Injection of a solution containing sterile, cooled 0.9% sodium chloride and 1% lidocaine with epinephrine (1:100,000). Each patient will receive a volume of solution equal to three times the estimated volume of the lipoma; the first cc of the injection will be lidocaine with epinephrine, and the remainder will be sterile normal saline. The solution will be cooled using an ice/saline bath at -1°C. Following the injection, the lipoma will be gently massaged for one minute to distribute the saline evenly.

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+