Last reviewed · How we verify
Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride: an Exploratory Study
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. Amendment to Protocol Feb 2026- Including and additional ARM of the study to evaluate the effectiveness of subcutaneous injections of warmed normal saline as a treatment option for lipomas.
Details
| Lead sponsor | West Virginia University |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | RECRUITING |
| Enrolment | 20 |
| Start date | 2025-05-08 |
| Completion | 2027-01 |
Conditions
- Lipoma
Interventions
- Cooled Sodium Chloride Injection
- Warmed Sodium Chloride Injection
Primary outcomes
- Post-Injection Pain (First Treatment) — 15 minutes post injection (treatment)
Pain is assessed using a scale of 0-10 reported by the patient, with 0 being no pain and 10 being the worst pain ever experienced. - Post-Injection Pain (Second Treatment) — 15 minutes post injection (treatment)
Pain is assessed using a scale of 0-10 reported by the patient, with 0 being no pain and 10 being the worst pain ever experienced. - Post-Injection Pain (Third Treatment) — 15 minutes post injection (treatment)
Pain is assessed using a scale of 0-10 reported by the patient, with 0 being no pain and 10 being the worst pain ever experienced. - Post-Injection Pain (Forth Treatment) — 15 minutes post injection (treatment)
Pain is assessed using a scale of 0-10 reported by the patient, with 0 being no pain and 10 being the worst pain ever experienced. - Post-injection erythema (First Treatment) — 15 minutes post injection (treatment)
Post-injection erythema is assessed using a scale of 0-4 as per the Clinical Erythema Assessment grading scale with: 0 = clear, 1 = almost clear, 2 = mild erythema, 3 = moderate erythema, and 4 = severe erythema. The higher score indicates a worse outcome. - Post-injection erythema (Second Treatment) — 15 minutes post injection (treatment)
Post-injection erythema is assessed using a scale of 0-4 as per the Clinical Erythema Assessment grading scale with: 0 = clear, 1 = almost clear, 2 = mild erythema, 3 = moderate erythema, and 4 = severe erythema. The higher score indicates a worse outcome.
Countries
United States