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.)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Administered via intralipomal injection.
Matching vehicle placebo administered via intralipomal injection.
Gary D. Monheit, M.D.
Birmingham, Alabama, United States
Stacy R. Smith
San Diego, California, United States
Steven Grekin, D.O.
Warren, Michigan, United States
Joel Schlessinger, M.D.
Omaha, Nebraska, United States
Number of Participants With Adverse Events (AEs)
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.
Time frame: Up to 24 weeks
Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities
An abnormality is defined as a value outside the limits of the expanded normal range/notable range.
Time frame: 24 weeks
Number of Participants With Clinically Significant Changes in Vital Signs or Weight
Time frame: Up to 24 weeks
Number of Participants With Positive Histopathology Results at Screening
A needle core tissue sample biopsy was performed at screening for all treated lipomas.
Time frame: Screening (prior to randomization)
Number of Participants With Positive Histopathology Results at Week 20
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.
Time frame: Week 20
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David J. Goldberg, M.D.
Westwood, New Jersey, United States
Neil S. Sadick, M.D.
New York, New York, United States
Michael H. Gold, M.D.
Nashville, Tennessee, United States
Percentage of Participants With Complete Clearance or ≥ 75% Clearance
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.
Time frame: Baseline and week 20 (8 weeks after last dose)
Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas
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.
Time frame: Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment)