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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating lipomas, which are harmless, fatty lumps under the skin. Researchers aim to determine if injecting a cooled saltwater solution (Cooled Sodium Chloride Injection) directly into the lipomas can shrink them without surgery. This approach may provide a more comfortable and targeted option compared to other fat-freezing treatments. Individuals with at least one diagnosed lipoma, not located on the face, may qualify for this study. As a Phase 1/Phase 2 trial, the research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial group, offering participants a chance to contribute to innovative treatment development.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this technique is safe for treating lipomas?

Research has shown that cooled salt water injections for treating lipomas are generally well-tolerated. Sodium chloride, or salt water, is a common solution in medical treatments. The injection includes a cooled mixture with a small amount of lidocaine (a numbing agent) and epinephrine (a type of adrenaline).

Although few studies have examined this exact method in humans, salt water injections are not considered dangerous. In other medical procedures, these injections rarely cause serious side effects.

Animal studies with similar treatments have shown few side effects, suggesting the procedure is usually safe. Since this trial is in the early stages (Phase 1/2), it primarily focuses on assessing safety and patient tolerance. Any potential risks are closely monitored, and the trial is designed to ensure participant safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard surgical treatments for lipomas, the cooled sodium chloride injection offers a non-invasive alternative. This treatment is unique because it uses a cooled saline solution, combined with lidocaine and epinephrine, to potentially break down lipomas without surgery. Researchers are excited because this approach could reduce recovery time and discomfort, offering a simpler, less intrusive method for treating these benign tumors while maintaining effectiveness.

What evidence suggests that cooled sodium chloride injection might be an effective treatment for lipomas?

Initial findings suggest that cooled saltwater injections, which participants in this trial will receive, might help reduce the size of lipomas, non-cancerous fatty lumps. A previous study with pigs showed that injecting a cooled liquid into fat tissue led to a 55% reduction in thickness. This process, similar to the proposed method for lipomas in this trial, shows potential effectiveness. The technique likely works by applying cold directly to the lipomas, potentially shrinking them without surgery. Although data on humans is limited, the results in animals are promising and suggest a new, non-invasive option for those seeking treatment for lipomas. ^{1 6 7 8 9}

Who Is on the Research Team?

Jessica Patterson, MD

Principal Investigator

West Virginia University-Dermatology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

trialx.com

trialx.com/clinical-trials/listings/316123/lipomas-treated-with-subcutaneous-injections-of-cooled-sodium-chloride/

Lipomas Treated with Subcutaneous Injections of Cooled ...

This exploratory study aims to evaluate the effectiveness of subcutaneous injections of cooled normal saline as a treatment option for lipomas.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/16310057/

Lipomas treated with subcutaneous deoxycholate injections

Results: All lipomas decreased in size (mean area reduction, 75%; range, 37%-100%) as determined by clinical measurement (with ultrasound confirmation in one ...

3.

frontiersin.org

frontiersin.org/journals/veterinary-science/articles/10.3389/fvets.2025.1630506/pdf

Pilot study evaluating lipoma reduction with injected ...

In the swine study, coolant was injected into subcutaneous adipose tissue and led to reduction in thickness and lobular panniculitis, similar to ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12312678/

Pilot study evaluating lipoma reduction with injected ...

A prior study undertaken in pigs showed a 55% (±6) reduction in adipose tissue thickness following injection of various biocompatible ice slurries compared with ...

5.

malacards.org

malacards.org/card/pleomorphic_lipoma

Pleomorphic Lipoma

Cooled Sodium Chloride Injection. 8, Evaluation of Safety and Efficiency of Metreleptin Treatment for Patients With Multiple Symmetric Lipomatosis (MSL) ...

6.

medefilinc.com

medefilinc.com/wp-content/uploads/2023/07/SDS-Sodium-Chloride-Injection-USP-Rev.-002.pdf

SODIUM CHLORIDE INJECTION, USP, 0.9% 1. 2. 3.

SODIUM CHLORIDE INJECTION, USP, 0.9%. Safety Data Sheet. According to 29 CFR 1910.1200 (g) [Federal Register Vol. 77, No. 58 Dated March 26, 2012]. Date of ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40746970/

Pilot study evaluating lipoma reduction with injected ...

Objective: This study aimed to assess the adverse event profile following injection of canine lipomas with BXT-786 coolant, and to assess ...

8.

medline.com

medline.com/media/catalog/Docs/MSDS/MSD_SDSD15808.pdf

SAFETY DATA SHEET

Keep containers tightly closed in a cool, well-ventilated place. Store at room temperature 25. °C (77 °F). Avoid excessive heat. Incompatible ...

9.

login.ehs.com

login.ehs.com/CompanyLogin?companyGuid=60BBBCFA-FE39-4844-A79D-86123E2EAD1B&returnUrl=60BBBCFA-FE39-4844-A79D-86123E2EAD1B%2Febinder%2Fpdf%2F%3FproductID%3D133989518

SODIUM CHLORIDE 0.9% INJECTION SAFETY DATA ...

HAZARD(S) IDENTIFICATION. Physical hazards. Not classified. Health hazards. Not classified. OSHA defined hazards. Not classified. Label elements.