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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


Phase 2
18 Years
65 Years
Not Enrolling
Both
Lipoma

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Trial Information

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


The purpose of this research is to compare the safety and effectiveness of three different
concentrations (amount of study drug in a liquid preparation) of an investigational drug
(sodium deoxycholate for injection) solution against a placebo (a solution that looks
similar but does not have any active drug in it) in the treatment of superficial lipomas.
Sodium deoxycholate for injection is a chemical similar to the one produced by the body. A
lipoma is a fatty lump typically located on the trunk, shoulder, arms and legs. For the
purposes of this study, only lipomas on the trunk, arms, legs or neck will be treated.
(Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles or feet
will not be treated.)


Inclusion Criteria:



- One or more lipomas, based on clinical diagnosis, which are accessible for treatment
and assessment, are quantifiable along at least two perpendicular diameters, and have
the following characteristics:

- History of slow growth followed by dormancy, and stable for at least six months.

- Greatest length by greatest perpendicular width between 1 and 16 square
centimeters

- Discrete, oval tor rounded in shape, not hard or attached to underlying tissue.

- Located on the trunk, arms, legs, or neck.

- Signed informed consent.

Exclusion Criteria:

- Absence of significant medical conditions that could affect safety.

- History of treatment for lipomas.

- Treatment with an investigational agent within 30 days before ATX-101 treatment.

Type of Study:

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

Outcome Measure:

Lipoma size reduction

Outcome Time Frame:

24 Weeks

Safety Issue:

No

Principal Investigator

Patricia S. Walker, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Kythera Biopharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

ATX-101-07-05

NCT ID:

NCT00608842

Start Date:

November 2007

Completion Date:

October 2008

Related Keywords:

  • Lipoma
  • Lipoma

Name

Location

Gary D. Monheit, M.D.Birmingham, Alabama  35205
Stacy R. SmithSan Diego, California  92123
Steven Grekin, D.O.Warren, Michigan  48088
Joel Schlessinger, M.D.Omaha, Nebraska  68144
David J. Goldberg, M.D.Westwood, New Jersey  07675
Neil S. Sadick, M.D.New York, New York  10021
Michael H. Gold, M.D.Nashville, Tennessee  37215