84
Participants
Start Date
December 31, 2013
Primary Completion Date
June 30, 2014
Study Completion Date
June 30, 2014
Deoxycholic Acid Injection
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Placebo
Phosphate buffered saline placebo for injection
Cold Compress
A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.
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.
Loratadine
Loratadine 10 mg orally from Day -7 until Day 7
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.
Compression Chin Strap
A compression chin strap was applied 15 minutes after dosing for at least 24 hours.
Investigational Site, Tempe
Lead Sponsor
Kythera Biopharmaceuticals
INDUSTRY