Lipomas Treated with Subcutaneous Injections of Cooled Sodium Chloride

Phase 1

Recruiting

• Conditions: Lipoma
• Interventions: Drug: Cooled Sodium Chloride Injection

• Registration Number: NCT06820164
• Lead Sponsor: West Virginia University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-02-05
• Study First Posted: 2025-02-11
• Status Verified: 2025-03
• Study Start: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cooled Sodium Chloride Injection	Cooled Sodium Chloride Injection	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.

Primary Outcome Measures

Name	Time	Method
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 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 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 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.
Change in Lipoma Size	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.

Trial Locations

Locations (1)

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States