Phase 2 Study for the Treatment of Superficial Lipomas

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kythera Biopharmaceuticals
• Treatments: Deoxycholic Acid

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