Clinical Trial: Phase 2 Study for the Treatment of Superficial Lipomas

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 S

Brief Summary: 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.

Detailed Summary: 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.)
Sponsor: Kythera Biopharmaceuticals

Current Primary Outcome:

• Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 24 weeks ]

  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.

• Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities [ Time Frame: 24 weeks ]
  An abnormality is defined as a value outside the limits of the expanded normal range/notable range.
• 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 [ Time Frame: Screening (prior to randomization) ]
• Percentage of Participants With Complete Clearance or ≥ 75% Clearance [ Time Frame: Baseline and week 20 (8 weeks after last dose) ]

  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 in the Sum of the Areas of All Treated Lipomas [ Time Frame: Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment) ]
  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.

Original Secondary Outcome: Safety: Laboratory tests, ECG, Medical Evaluations [ Time Frame: 24 Weeks ]

Information By: Kythera Biopharmaceuticals

Dates:
Date Received: January 23, 2008
Date Started: November 2007
Date Completion:
Last Updated: December 8, 2015
Last Verified: December 2015