Funding sources This study was supported by Bayer HealthCare, AG and KYTHERA Biopharmaceuticals, Inc. The sponsors were responsible for the study design, co-ordination and collation of data provided by the investigators. The authors were responsible for data analysis, manuscript preparation and the decision to submit the manuscript for publication.
Reduction of unwanted submental fat with ATX-101 (deoxycholic acid), an adipocytolytic injectable treatment: results from a phase III, randomized, placebo-controlled study†
Article first published online: 18 FEB 2014
© 2013 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
British Journal of Dermatology
Volume 170, Issue 2, pages 445–453, February 2014
How to Cite
Rzany, B., Griffiths, T., Walker, P., Lippert, S., McDiarmid, J. and Havlickova, B. (2014), Reduction of unwanted submental fat with ATX-101 (deoxycholic acid), an adipocytolytic injectable treatment: results from a phase III, randomized, placebo-controlled study. British Journal of Dermatology, 170: 445–453. doi: 10.1111/bjd.12695
Conflicts of interest B.R., T.G. and J.M. have acted as advisers and lecturers for Bayer HealthCare, Intendis GmbH. B.H. and S.L. are employees of Bayer HealthCare. P.W. is a former employee of, and is now an adviser to, KYTHERA Biopharmaceuticals, Inc.
Plain language summary available online
- Issue published online: 18 FEB 2014
- Article first published online: 18 FEB 2014
- Accepted manuscript online: 22 OCT 2013 02:05PM EST
- Manuscript Accepted: 10 OCT 2013
- Bayer HealthCare
- KYTHERA Biopharmaceuticals, Inc.
Unwanted submental fat (SMF) is aesthetically unappealing, but methods of reduction are either invasive or lack evidence for their use. An injectable approach with ATX-101 (deoxycholic acid) is under investigation.
To evaluate the efficacy and safety of ATX-101 for the reduction of unwanted SMF.
In this double-blind, placebo-controlled, phase III study, 363 patients with moderate/severe SMF were randomized to receive ATX-101 (1 or 2 mg cm−2) or placebo injections into their SMF at up to four treatment sessions ~28 days apart, with a 12-week follow-up. The co-primary efficacy endpoints were the proportions of treatment responders [patients with ≥ 1-point improvement in SMF on the 5-point Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)] and patients satisfied with their face and chin appearance on the Subject Self-Rating Scale (SSRS). Secondary endpoints included skin laxity, calliper measurements and patient-reported outcomes. Adverse events were monitored.
Significantly more ATX-101 recipients met the primary endpoint criteria vs. placebo: on the clinician scale, 59·2% and 65·3% of patients treated with ATX-101 1 and 2 mg cm−2, respectively, were treatment responders vs. 23·0% for placebo (CR-SMFRS; P < 0·001); on the patient scale, 53·3% and 66·1%, respectively, vs. 28·7%, were satisfied with their face/chin appearance (SSRS; P < 0·001). Calliper measurements showed a significant reduction in SMF (P < 0·001), skin laxity was not worsened and patients reported improvements in the severity and psychological impact of SMF with ATX-101 vs. placebo. Most adverse events were transient and associated with the treatment area.
ATX-101 was effective and well tolerated for nonsurgical SMF reduction.