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Completed

NCT Number: NCT00608842

Phase 2 Study for the Treatment of Superficial Lipomas

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.

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Key information

Conditions

Lipoma Neoplasms Neoplasms by Histologic Type Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gary D. Monheit, M.D., Birmingham, Alabama, United States

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About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deoxycholic acid Injection

Drug

Administered via intralipomal injection.

Other names: sodium deoxycholate, ATX-101

Placebo

Drug

Matching vehicle placebo administered via intralipomal injection.

Primary outcomes

  1. 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.

  2. 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.

  3. Number of Participants With Clinically Significant Changes in Vital Signs or Weight

    Time frame: Up to 24 weeks

  4. 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.

  5. 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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Kythera Biopharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Feb 6, 2008
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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