Phase 2 Study for the Treatment of Superficial Lipomas

Lipoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608842
• Other study ID #: ATX-101-07-05
• Status: Completed
• Phase: Phase 2
• First received: January 23, 2008
• Last updated: December 8, 2015
• Start date: November 2007
• Est. completion date: January 2010

Study information

• Verified date: December 2015
• Source: Kythera Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 2010
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lipoma

Intervention

Drug:
• Deoxycholic Acid Injection
Administered via intralipomal injection.
• Placebo
Matching vehicle placebo administered via intralipomal injection.

Locations

Country	Name	City	State
United States	Gary D. Monheit, M.D.	Birmingham	Alabama
United States	Michael H. Gold, M.D.	Nashville	Tennessee
United States	Neil S. Sadick, M.D.	New York	New York
United States	Joel Schlessinger, M.D.	Omaha	Nebraska
United States	Stacy R. Smith	San Diego	California
United States	Steven Grekin, D.O.	Warren	Michigan
United States	David J. Goldberg, M.D.	Westwood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kythera Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 24 weeks	No
Primary	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.	24 weeks	No
Primary	Number of Participants With Clinically Significant Changes in Vital Signs or Weight		Up to 24 weeks	No
Primary	Number of Participants With Positive Histopathology Results at Screening	A needle core tissue sample biopsy was performed at screening for all treated lipomas.	Screening (prior to randomization)	No
Primary	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.	Week 20	No
Secondary	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.	Baseline and week 20 (8 weeks after last dose)	No
Secondary	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.	Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment)	No