CONTOUR Australia: Condition of Submental Fullness and Treatment Outcomes with Belkyra Registry

Abstract

Background: Submental fat (SMF) contributes to an aged or overweight appearance that may negatively impact an individual’s psychological well-being. Deoxycholic acid (ATX-101) is an injectable formulation of deoxycholic acid approved to treat SMF. The Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR) Australia study was designed to understand treatment patterns and outcomes with ATX-101 in Australia. Methods: CONTOUR Australia was a phase 4, prospective, observational, multicenter registry that enrolled adults considering treatment for SMF reduction. Results: The registry enrolled 86 patients from six sites. Significant changes from baseline through the end of treatment indicated improvement in mild to moderate fullness associated with SMF on the Clinician-Reported SMF Rating Scale and the Patient-Reported SMF Rating Scale, improvement in SMF-associated psychological impact after treatment on the Patient-Reported SMF Impact Scale, no overall worsening in skin laxity based on Submental Skin Laxity Grade, and increased patient satisfaction with the face/chin on the Subject Self-Rating Scale after receiving treatment. Adverse events were all mild and mostly related to the injection site (ie, bruising and swelling). Conclusion: CONTOUR Australia observed clinically meaningful and significant outcomes and further supports ATX-101 as a well-tolerated and effective treatment for SMF reduction.