Patient Experience Study of Deoxycholic Acid Injection

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.

Timeline

Start

2013-12

Primary completion

2014-06

Completion

2014-06

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Paradigm 1 / Deoxycholic Acid Injection vs Paradigm 2 / Deoxycholic Acid Injection; p = 0.6803 NCT02007434 ↗

registry analysis (superiority or other test); Paradigm 1 / Deoxycholic Acid Injection vs Paradigm 3 / Deoxycholic Acid Injection; p = 0.5206 NCT02007434 ↗

registry analysis (superiority or other test); Paradigm 1 / Deoxycholic Acid Injection vs Paradigm 4 / Deoxycholic Acid Injection; p = 0.6060 NCT02007434 ↗

Publications

• Dover JS, Kenkel JM, Carruthers A, Lizzul PF, Gross TM, Subramanian M, Beddingfield FC 3rd. Management of Patient Experience With ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat. Dermatol Surg. 2016 Nov;42 Suppl 1:S288-S299. doi: 10.1097/DSS.0000000000000908.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Deoxycholic Acid	Unknown	2 unknown	Subcutaneous
Background	Epinephrine	Other / unclassified	—	Subcutaneous
Background	Ibuprofen	Small molecule	600 mg	Oral
Background	Lidocaine	Other / unclassified	1 %	Topical
Background	Lidocaine	Other / unclassified	4 %	Topical
Background	Loratadine	Small molecule	10 mg	Oral

Indications

No indication recorded.