Clinical trial NCT00608842: Phase 2 Study for the Treatment of Superficial Lipomas
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 Superficial Lipomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lipoma
Lead sponsor: Kythera Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.)

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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 24 weeks
measure: Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities
timeFrame: 24 weeks
measure: Number of Participants With Clinically Significant Changes in Vital Signs or Weight
timeFrame: Up to 24 weeks
measure: Number of Participants With Positive Histopathology Results at Screening
timeFrame: Screening (prior to randomization)
measure: Number of Participants With Positive Histopathology Results at Week 20
timeFrame: Week 20
Secondary outcomes:
measure: Percentage of Participants With Complete Clearance or ≥ 75% Clearance
timeFrame: Baseline and week 20 (8 weeks after last dose)
measure: Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas
timeFrame: Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Gary D. Monheit, M.D.
state: Alabama
city: San Diego
country: United States
facility: Stacy R. Smith
state: California
city: Warren
country: United States
facility: Steven Grekin, D.O.
state: Michigan
city: Omaha
country: United States
facility: Joel Schlessinger, M.D.
state: Nebraska
city: Westwood
country: United States
facility: David J. Goldberg, M.D.
state: New Jersey
city: New York
country: United States
facility: Neil S. Sadick, M.D.
state: New York
city: Nashville
country: United States
facility: Michael H. Gold, M.D.
state: Tennessee
Study officials:
affiliation: Kythera Biopharmaceuticals, Inc.
name: Patricia S. Walker, M.D., Ph.D.
role: STUDY_DIRECTOR
References: