Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of the Pharmacokinetics, Safety, and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas
18 Years
65 Years
Both
Lipoma
Trial Information
Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of the Pharmacokinetics, 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.
- Stable body weight with a body mass index of less than 30.
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Safety: Laboratory tests, ECG, Medical Evaluations
Principal Investigator
Stacy R. Smith, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Therapeutics Clinical Research
Authority:
United States: Food and Drug Administration
Study ID:
ATX-101-06-04
NCT ID:
NCT00422188
Start Date:
December 2006
Completion Date:
October 2007
Related Keywords:
- Lipoma
- Lipoma
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