Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

Study Overview
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Brief Summary
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The purpose of this research is to compare the safety and effectiveness of 4 different concentrations of deoxycholic acid injection against a placebo in the treatment of superficial lipomas.

Detailed Description
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A lipoma is a fatty lump typically located on the trunk, shoulder, arms or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)

Official Title
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Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Dose-Escalation Study of the Pharmacokinetics, Safety, and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas

Conditions
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Lipoma

Intervention / Treatment
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* Drug: Deoxycholic Acid Injection
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: One or more lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics: History of slow growth followed by dormancy, and stable for at least 6 months. Greatest length by greatest perpendicular width between 1 and 16 square centimeters, inclusive Discrete, oval to rounded in shape, not hard or attached to underlying tissue Located on the trunk, arms, legs, or neck Stable body weight with a body mass index of less than 30 kg/m² Signed informed consent Exclusion Criteria: Absence of significant medical conditions that could affect safety History of surgical treatment for lipomas Treatment with an investigational agent within 30 days before ATX-101 treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deoxycholic Acid Injection 0.5%<br>Participants received 0.5% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals. | Drug: Deoxycholic Acid Injection<br>* Administered via intralipomal injection.<br>* Other names: Sodium deoxycholate;|
| Experimental: Deoxycholic Acid Injection 1.0%<br>Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals. | Drug: Deoxycholic Acid Injection<br>* Administered via intralipomal injection.<br>* Other names: Sodium deoxycholate;|
| Experimental: Deoxycholic Acid Injection 2.0%<br>Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals. | Drug: Deoxycholic Acid Injection<br>* Administered via intralipomal injection.<br>* Other names: Sodium deoxycholate;|
| Experimental: Deoxycholic Acid Injection 4.0%<br>Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals. | Drug: Deoxycholic Acid Injection<br>* Administered via intralipomal injection.<br>* Other names: Sodium deoxycholate;|
| Placebo Comparator: Placebo<br>Participants received matching vehicle placebo administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals. | Drug: Placebo<br>* Administered via intralipomal injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessments of Safety with Laboratory tests |  | up to 16 weeks | 
| Assessments of Safety with ECG |  | up to 16 weeks | 
| Assessments of Safety with Medical Evaluations |  | up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipoma size reduction |  | up to 16 weeks |