Patient Experience Study of Deoxycholic Acid Injection

NCT02007434 ↗

Phase 3 Completed 84 enrolled Kythera Biopharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

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

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	Small molecule	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.