Patient Experience Study of Deoxycholic Acid Injection

PHASE3CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Moderate or Severe Submental Fullness
Interventions
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.

Trial Locations (1)

85283

Investigational Site, Tempe

Sponsors
All Listed Sponsors
lead

Kythera Biopharmaceuticals

INDUSTRY