Neoplasms

All Conditions

Lipoma

Neoplasms, Adipose Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Agents

All Drugs and Chemicals

Deoxycholic Acid

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.

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.

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.

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.

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.

Deoxycholic Acid Injection

Placebo

Stacy R. Smith, M.D.

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.)

Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

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

Kythera Biopharmaceuticals

Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.

Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.

Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.

Participants received matching vehicle placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.

Matching vehicle placebo administered via intralipomal injection.

Patricia S. Walker, M.D., Ph.D.

The purpose of this research is to compare the safety and effectiveness of 3 different concentrations of deoxycholic acid for 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.)

Phase 2 Study for the Treatment of Superficial Lipomas

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas

Severity of AEs was determined using the following scale:

Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: "Was there a reasonable possibility that the event may have been caused by treatment with study material?" A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator's or sponsor's opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard.

An abnormality is defined as a value outside the limits of the expanded normal range/notable range.

A needle core tissue sample biopsy was performed at screening for all treated lipomas.

After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised.

At randomization 1 to 3 lipomas were selected for treatment. Lipomas were measured in 3 dimensions (longest length, perpendicular width, and height if possible) using digital calipers.

Complete clearance indicates target lipoma(s) not present or detectable, and ≥ 75% clearance is defined as a ≥ 75% reduction from baseline in the area of target lipoma(s).

For participants with \> 1 target lipoma, the total area of all target lipomas was used in the calculation of response.

Percent change from baseline was calculated as the baseline total lipoma area - postbaseline total lipoma area / baseline total lipoma area \* 100. A positive change indicates a reduction in size.

Deoxycholic Acid 1%

Deoxycholic Acid 2%

Deoxycholic Acid 4%

Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.

Total

Age, Continuous

Sex: Female, Male

Modified intent-to-treat (MITT) population included all randomized participants who had received at least 1 dose of study material and who had at least 1 postbaseline observation.

Clinical Trial Disclosure

Any adverse event

Any treatment-related adverse event

Any serious adverse event

Any severe adverse event

Any adverse event leading to drug discontinuation

Safety population (all participants who received at least 1 dose of study medication)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Deoxycholic Acid Injection for the Treatment of Superficial Lipomas	NCT00422188	Lipoma	Deoxycholic Aci... Placebo	18 Years - 65 Years	Kythera Biopharmaceuticals
Phase 2 Study for the Treatment of Superficial Lipomas	NCT00608842	Lipoma	Deoxycholic Aci... Placebo	18 Years - 65 Years	Kythera Biopharmaceuticals

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