Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride
ConditionLipoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest Virginia University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
At least one clinically diagnosed subcutaneous lipoma
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Cooled Sodium Chloride Injection
DrugA 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
DrugA 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).
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Cooled Sodium Chloride InjectionExperimental treatment 1 intervention
Group B: Warmed Sodium Chloride InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
15 minutes post injection (treatment)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov