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Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

Primary Purpose

Lipoma

Status
Completed
Phase
Phase 1
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 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 by greatest perpendicular width between 1 and 16 square centimeters, inclusive
    • Discrete, oval to rounded in shape, not hard or attached to underlying tissue
    • Located on the trunk, arms, legs, or neck
  • Stable body weight with a body mass index of less than 30 kg/m²
  • Signed informed consent

Exclusion Criteria:

  • Absence of significant medical conditions that could affect safety
  • History of surgical treatment for lipomas
  • Treatment with an investigational agent within 30 days before ATX-101 treatment

Sites / Locations

  • Therapeutics Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Deoxycholic Acid Injection 0.5%

Deoxycholic Acid Injection 1.0%

Deoxycholic Acid Injection 2.0%

Deoxycholic Acid Injection 4.0%

Placebo

Arm Description

Participants received 0.5% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.

Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.

Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.

Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.

Participants received matching vehicle placebo administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.

Outcomes

Primary Outcome Measures

Assessments of Safety with Laboratory tests
Assessments of Safety with ECG
Assessments of Safety with Medical Evaluations

Secondary Outcome Measures

Lipoma size reduction

Full Information

First Posted
January 11, 2007
Last Updated
December 8, 2015
Sponsor
Kythera Biopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00422188
Brief Title
Deoxycholic Acid Injection for the Treatment of Superficial Lipomas
Official Title
Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Dose-Escalation Study of the Pharmacokinetics, 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
January 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (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 4 different concentrations of deoxycholic acid 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 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deoxycholic Acid Injection 0.5%
Arm Type
Experimental
Arm Description
Participants received 0.5% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
Arm Title
Deoxycholic Acid Injection 1.0%
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 5 mL for 2 treatments at 28-day intervals.
Arm Title
Deoxycholic Acid Injection 2.0%
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 5 mL for 2 treatments at 28-day intervals.
Arm Title
Deoxycholic Acid Injection 4.0%
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 5 mL for 2 treatments at 28-day intervals.
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 5 mL for 2 treatments at 28-day intervals.
Intervention Type
Drug
Intervention Name(s)
Deoxycholic Acid Injection
Other Intervention Name(s)
ATX-101, Sodium deoxycholate
Intervention Description
Administered via intralipomal injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered via intralipomal injection.
Primary Outcome Measure Information:
Title
Assessments of Safety with Laboratory tests
Time Frame
up to 16 weeks
Title
Assessments of Safety with ECG
Time Frame
up to 16 weeks
Title
Assessments of Safety with Medical Evaluations
Time Frame
up to 16 weeks
Secondary Outcome Measure Information:
Title
Lipoma size reduction
Time Frame
up to 16 weeks

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 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 by greatest perpendicular width between 1 and 16 square centimeters, inclusive Discrete, oval to rounded in shape, not hard or attached to underlying tissue Located on the trunk, arms, legs, or neck Stable body weight with a body mass index of less than 30 kg/m² Signed informed consent Exclusion Criteria: Absence of significant medical conditions that could affect safety History of surgical 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
Stacy R. Smith, M.D.
Organizational Affiliation
Therapeutics Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

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Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

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