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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A 30-gauge, 0.5-inch needle attached to a 3 mL syringe will be used to directly inject the solution transcutaneously into the lipoma. Injection of a solution containing sterile, cooled 0.9% sodium chloride and 1% lidocaine with epinephrine (1:100,000).
A 30-gauge, 0.5-inch needle attached to a 3 mL syringe will be used to directly inject the solution transcutaneously into the lipoma. Injection of a solution containing sterile, warmed 0.9% sodium chloride and 1% lidocaine with epinephrine (1:100,000).
West Virginia University
Morgantown, West Virginia, United States
RECRUITINGPost-Injection Pain (First 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.
Time frame: 15 minutes post injection (treatment)
Post-Injection Pain (Second 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.
Time frame: 15 minutes post injection (treatment)
Post-Injection Pain (Third 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.
Time frame: 15 minutes post injection (treatment)
Post-Injection Pain (Forth 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.
Time frame: 15 minutes post injection (treatment)
Post-injection erythema (First 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.
Time frame: 15 minutes post injection (treatment)
Post-injection erythema (Second 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.
Time frame: 15 minutes post injection (treatment)
Post-injection erythema (Third 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.
Time frame: 15 minutes post injection (treatment)
Post-injection erythema (Forth 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.
Time frame: 15 minutes post injection (treatment)
Change in Lipoma Size (Second Treatment)
Change in Lipoma Size from the First Treatment (Baseline) to the Second Treatment. There is a 4 week interval between each treatment. Lipoma size is assessed using approximate lipoma area (cm × cm) determined by ultrasound, with the final percentage change being the following quotient: \[(final area - initial area) ÷ initial area\] × 100.
Time frame: Baseline to Second Treatment (4-week interval between treatments)
Change in Lipoma Size (Third Treatment)
Change in Lipoma Size from the First Treatment (Baseline) to the Third Treatment. Lipoma size is assessed using approximate lipoma area (cm × cm) determined by ultrasound, with the final percentage change being the following quotient: \[(final area - initial area) ÷ initial area\] × 100.
Time frame: Baseline to Third Treatment (4-week interval between treatments)
Change in Lipoma Size (Forth Treatment)
Change in Lipoma Size from the First Treatment (Baseline) to the Forth Treatment. Lipoma size is assessed using approximate lipoma area (cm × cm) determined by ultrasound, with the final percentage change being the following quotient: \[(final area - initial area) ÷ initial area\] × 100.
Time frame: Baseline to Forth Treatment (4-week interval between treatments)
Change in Lipoma Size (12 weeks following the Fourth Treatment)
Change in Lipoma Size from the First Treatment (Baseline) to 12 weeks following the Fourth Treatment. Lipoma size is assessed using approximate lipoma area (cm × cm) determined by ultrasound, with the final percentage change being the following quotient: \[(final area - initial area) ÷ initial area\] × 100.
Time frame: From Baseline to 12 weeks following the Fourth Treatment
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