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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.
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.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deoxycholic Acid Injection 0.5% | Experimental | 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. |
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| Deoxycholic Acid Injection 1.0% | Experimental | 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. |
|
| Deoxycholic Acid Injection 2.0% | Experimental | 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. |
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| Deoxycholic Acid Injection 4.0% | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deoxycholic Acid Injection | Drug | Administered via intralipomal injection. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Lipoma size reduction | up to 16 weeks |
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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:
Stable body weight with a body mass index of less than 30 kg/m²
Signed informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacy R. Smith, M.D. | Therapeutics Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutics Clinical Research | San Diego | California | 92123 | United States |
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| ID | Term |
|---|---|
| D008067 | Lipoma |
| ID | Term |
|---|---|
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| ID | Term |
|---|---|
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug | Administered via intralipomal injection. |
|
| D011083 |
| Polycyclic Compounds |
| D002757 | Cholanes |