Cooled Sodium Chloride for Lipoma
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.12345Why 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.16789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous injections of cooled sodium chloride for lipoma treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cooled Sodium Chloride Injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
West Virginia University
Lead Sponsor