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NCT Number: NCT06820164

Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

West Virginia University

Morgantown, West Virginia, 26505, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

  1. Post-Injection Pain (First Treatment)

    Time frame: 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.

  2. Post-Injection Pain (Second Treatment)

    Time frame: 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.

  3. Post-Injection Pain (Third Treatment)

    Time frame: 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.

  4. Post-Injection Pain (Forth Treatment)

    Time frame: 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.

  5. Post-injection erythema (First Treatment)

    Time frame: 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.

  6. Post-injection erythema (Second Treatment)

    Time frame: 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.

  7. Post-injection erythema (Third Treatment)

    Time frame: 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.

  8. Post-injection erythema (Forth Treatment)

    Time frame: 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.

  9. Change in Lipoma Size (Second Treatment)

    Time frame: 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.

  10. Change in Lipoma Size (Third Treatment)

    Time frame: 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.

  11. Change in Lipoma Size (Forth Treatment)

    Time frame: 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.

  12. Change in Lipoma Size (12 weeks following the Fourth Treatment)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Patterson, MD

CONTACT

[email protected]

304-598-4865

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride: an Exploratory Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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