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
Overview
- Phase
- Phase 2
- Intervention
- Deoxycholic Acid Injection
- Conditions
- Lipoma
- Sponsor
- Kythera Biopharmaceuticals
- Enrollment
- 62
- Locations
- 7
- Primary Endpoint
- Number of Participants With Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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 Description
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.)
Investigators
Eligibility Criteria
Inclusion Criteria
- •One or more lipomas, based on clinical and histological 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 multiplied by greatest perpendicular width between 1 and 16 cm², inclusive
- •Discrete, oval to rounded in shape, not hard or attached to underlying tissue
- •Without changes in overlying skin (ie, inflammation, pain or tenderness, hyperpigmentation)
- •Located on the trunk, arms, legs, or neck
- •Signed informed consent.
Exclusion Criteria
- •Absence of significant medical conditions that could affect safety
- •History of surgical or deoxycholate treatment for lipomas
- •Treatment with an investigational agent within 30 days before ATX-101 treatment
Arms & Interventions
Deoxycholic Acid 1%
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.
Intervention: Deoxycholic Acid Injection
Deoxycholic Acid 2%
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.
Intervention: Deoxycholic Acid Injection
Deoxycholic Acid 4%
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.
Intervention: Deoxycholic Acid Injection
Placebo
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.
Intervention: Placebo
Outcomes
Primary Outcomes
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)
A needle core tissue sample biopsy was performed at screening for all treated lipomas.
Number of Participants With Positive Histopathology Results at Week 20
Time Frame: 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.
Secondary Outcomes
- Percentage of Participants With Complete Clearance or ≥ 75% Clearance(Baseline and week 20 (8 weeks after last dose))
- Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas(Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment))