Phase 2 Study for the Treatment of Superficial Lipomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00608842
First received: January 23, 2008
Last updated: December 8, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Lipoma
Drug: Deoxycholic Acid Injection
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Kythera Biopharmaceuticals:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of Participants With Positive Histopathology Results at Screening [ Time Frame: Screening (prior to randomization) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percentage of Participants With Complete Clearance or ≥ 75% Clearance [ Time Frame: Baseline and week 20 (8 weeks after last dose) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 62
Study Start Date: November 2007
Study Completion Date: January 2010
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Deoxycholic Acid Injection
Administered via intralipomal injection.
Other Names:
  • sodium deoxycholate
  • ATX-101
Experimental: 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.
Drug: Deoxycholic Acid Injection
Administered via intralipomal injection.
Other Names:
  • sodium deoxycholate
  • ATX-101
Experimental: 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.
Drug: Deoxycholic Acid Injection
Administered via intralipomal injection.
Other Names:
  • sodium deoxycholate
  • ATX-101
Placebo Comparator: 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.
Drug: Placebo
Matching vehicle placebo administered via intralipomal injection.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608842

Locations
United States, Alabama
Gary D. Monheit, M.D.
Birmingham, Alabama, United States, 35205
United States, California
Stacy R. Smith
San Diego, California, United States, 92123
United States, Michigan
Steven Grekin, D.O.
Warren, Michigan, United States, 48088
United States, Nebraska
Joel Schlessinger, M.D.
Omaha, Nebraska, United States, 68144
United States, New Jersey
David J. Goldberg, M.D.
Westwood, New Jersey, United States, 07675
United States, New York
Neil S. Sadick, M.D.
New York, New York, United States, 10021
United States, Tennessee
Michael H. Gold, M.D.
Nashville, Tennessee, United States, 37215
Sponsors and Collaborators
Kythera Biopharmaceuticals
Investigators
Study Director: Patricia S. Walker, M.D., Ph.D. Kythera Biopharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00608842     History of Changes
Other Study ID Numbers: ATX-101-07-05 
Study First Received: January 23, 2008
Results First Received: December 8, 2015
Last Updated: December 8, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lipoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Deoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 11, 2016