Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

Lipoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422188
• Other study ID #: ATX-101-06-04
• Status: Completed
• Phase: Phase 1
• First received: January 11, 2007
• Last updated: December 8, 2015
• Start date: January 2007
• Est. completion date: November 2007

Study information

• Verified date: December 2015
• Source: Kythera Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lipoma

Intervention

Drug:
• Deoxycholic Acid Injection
Administered via intralipomal injection.
• Placebo
Administered via intralipomal injection.

Locations

Country	Name	City	State
United States	Therapeutics Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Kythera Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessments of Safety with Laboratory tests		up to 16 weeks	No
Primary	Assessments of Safety with ECG		up to 16 weeks	No
Primary	Assessments of Safety with Medical Evaluations		up to 16 weeks	No
Secondary	Lipoma size reduction		up to 16 weeks	No