At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Deoxycholic Acid Injection, Placebo, and 5 other interventions for Moderate or Severe Submental Fullness. Completed, enrolled 84 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Phosphate buffered saline placebo for injection
A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.
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 10 mg orally from Day -7 until Day 7
Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.
A compression chin strap was applied 15 minutes after dosing for at least 24 hours.