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Phase 2 Study for the Treatment of Superficial Lipomas

Primary Purpose

Lipoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Deoxycholic Acid Injection
Placebo
Sponsored by
Kythera Biopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gary D. Monheit, M.D.
  • Stacy R. Smith
  • Steven Grekin, D.O.
  • Joel Schlessinger, M.D.
  • David J. Goldberg, M.D.
  • Neil S. Sadick, M.D.
  • Michael H. Gold, M.D.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Deoxycholic Acid 1%

Deoxycholic Acid 2%

Deoxycholic Acid 4%

Placebo

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Number of Participants With Clinically Significant Changes in Vital Signs or Weight
Number of Participants With Positive Histopathology Results at Screening
A needle core tissue sample biopsy was performed at screening for all treated lipomas.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 23, 2008
Last Updated
December 8, 2015
Sponsor
Kythera Biopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00608842
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kythera Biopharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deoxycholic Acid 1%
Arm Type
Experimental
Arm Description
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.
Arm Title
Deoxycholic Acid 2%
Arm Type
Experimental
Arm Description
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.
Arm Title
Deoxycholic Acid 4%
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Deoxycholic Acid Injection
Other Intervention Name(s)
sodium deoxycholate, ATX-101
Intervention Description
Administered via intralipomal injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching vehicle placebo administered via intralipomal injection.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Up to 24 weeks
Title
Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities
Description
An abnormality is defined as a value outside the limits of the expanded normal range/notable range.
Time Frame
24 weeks
Title
Number of Participants With Clinically Significant Changes in Vital Signs or Weight
Time Frame
Up to 24 weeks
Title
Number of Participants With Positive Histopathology Results at Screening
Description
A needle core tissue sample biopsy was performed at screening for all treated lipomas.
Time Frame
Screening (prior to randomization)
Title
Number of Participants With Positive Histopathology Results at Week 20
Description
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.
Time Frame
Week 20
Secondary Outcome Measure Information:
Title
Percentage of Participants With Complete Clearance or ≥ 75% Clearance
Description
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.
Time Frame
Baseline and week 20 (8 weeks after last dose)
Title
Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas
Description
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.
Time Frame
Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia S. Walker, M.D., Ph.D.
Organizational Affiliation
Kythera Biopharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Gary D. Monheit, M.D.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Stacy R. Smith
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Steven Grekin, D.O.
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Joel Schlessinger, M.D.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
David J. Goldberg, M.D.
City
Westwood
State/Province
New Jersey
ZIP/Postal Code
07675
Country
United States
Facility Name
Neil S. Sadick, M.D.
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Michael H. Gold, M.D.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase 2 Study for the Treatment of Superficial Lipomas

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