Lipoma
Conditions
Brief summary
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.
Interventions
DRUGCooled Sodium Chloride Injection
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).
DRUGWarmed Sodium Chloride Injection
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).
Sponsors
West Virginia University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least one clinically diagnosed subcutaneous lipoma
Exclusion criteria
* Unable to give informed consent * Participant has a lipoma on the face * Lipomas located subfascial or within deep tissue (e.g., intramuscular lipomas) * Lipomas larger than 10 cm in diameter (fat deposits exceeding 500 mL in volume) * Rapidly growing lipomas * Lipomas exhibiting abnormal ultrasound findings (e.g., complex hyperechoic patterns, internal heterogeneity, or multilobulated appearance) * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Post-injection erythema (Third 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 (Forth 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. |
| Change in Lipoma Size (Second Treatment) | Baseline to Second Treatment (4-week interval between treatments) | 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. |
| Change in Lipoma Size (Third Treatment) | Baseline to Third Treatment (4-week interval between treatments) | 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. |
| Change in Lipoma Size (Forth Treatment) | Baseline to Forth Treatment (4-week interval between treatments) | 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. |
| Change in Lipoma Size (12 weeks following the Fourth Treatment) | From Baseline to 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. |
Countries
United States
Contacts
CONTACTJessica Patterson, MD
PRINCIPAL_INVESTIGATORJessica Patterson, MD
West Virginia University-Dermatology
Outcome results
None listed