NCT02007434

Patient Experience Study of Deoxycholic Acid Injection

A Single Center, Double-blind, Parallel-group, Two Factor Patient-Experience Management Study of ATX-101 (Deoxycholic Acid Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Kythera Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema.

Detailed description

This study evaluated the effects of four interventions, pre- and post-subcutaneous injections of deoxycholic acid injection relative to placebo in adults with submental fullness. Participants were randomized to either deoxycholic acid injection or placebo in a ratio of 4:1 and to one of four patient experience management paradigms. Participants were required to visit the research facility on 10 separate occasions for protocol-defined treatments, procedures, tests, and observations.

Conditions

• Moderate or Severe Submental Fullness

Interventions

Type	Name	Description
DRUG	Deoxycholic Acid Injection	Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
DRUG	Placebo	Phosphate buffered saline placebo for injection
OTHER	Cold Compress	A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.
DRUG	Lidocaine / Epinephrine	Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing.
DRUG	Loratadine	Loratadine 10 mg orally from Day -7 until Day 7
DRUG	Ibuprofen	Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.
OTHER	Compression Chin Strap	A compression chin strap was applied 15 minutes after dosing for at least 24 hours.

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-12-10
• Last updated: 2015-07-28
• Results posted: 2015-07-03

Locations

1 site across 1 country: United States