Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride

NCT06820164 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 2410045096
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipoma

Outcome Measures

Primary Outcomes (12)

• Post-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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  From Baseline to 12 weeks following the Fourth Treatment

Study Arms (2)

Cooled Sodium Chloride Injection

EXPERIMENTAL

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.

Drug: Cooled Sodium Chloride Injection

Warmed Sodium Chloride Injection

EXPERIMENTAL

Injection of a solution containing sterile, warm 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 saline vials and syringes will both be warmed using a Thermo Fisher Scientific dry bath calibrated to 55°C; a precise temperature stability will be achieved by using a mercury thermometer. Following the injection, the lipoma will be gently massaged for one minute to distribute the saline evenly.

Drug: Warmed Sodium Chloride Injection

Interventions

Cooled Sodium Chloride Injection DRUG

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).

Cooled Sodium Chloride Injection

Warmed Sodium Chloride Injection DRUG

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).

Warmed Sodium Chloride Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one clinically diagnosed subcutaneous lipoma

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26505, United States

RECRUITING

MeSH Terms

Conditions

Lipoma

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Jessica Patterson, MD

  West Virginia University-Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Patterson, MD

CONTACT

304-598-4865; jpatter5@hsc.wvu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 11, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)