Skip to main content
SpringerLink
Log in

Deoxycholic Acid: A Review in Submental Fat Contouring

  • Adis Drug Evaluation
  • Published:
American Journal of Clinical Dermatology Aims and scope Submit manuscript

Abstract

Deoxycholic acid is a secondary bile acid involved in dietary fat emulsification/solubilization that causes adipocyte lysis when injected into subcutaneous fat tissue. A 10 mg/mL injectable solution of synthetic deoxycholic acid (Kybella™; Belkyra™) is indicated in various countries, including the USA and several within Europe/the EU, to improve the appearance of moderate to severe convexity or fullness associated with submental fat (SMF) in adults, where it is currently the only approved treatment for fat below the chin. In several phase III trials conducted in this setting, injecting deoxycholic acid 2 mg/cm2 into the SMF reduced the convexity/fullness of moderate to severe SMF relative to placebo (with a single treatment comprising up to 50 injections, and up to six treatments given at least 1 month apart). These SMF benefits (which were measured subjectively by clinicians and recipients, as well as objectively, 12 weeks after the last treatment session) generally occurred without detriment to skin laxity and were largely maintained over extended follow-up (e.g. 2 years after treatment). Deoxycholic acid injections are generally well tolerated, with adverse events usually involving the treatment area, being mild to moderate in severity and resolving within approximately one treatment interval. However, not all patients with SMF may be suitable for deoxycholic acid therapy, making patient selection key to achieving desired aesthetic outcomes. Thus, deoxycholic acid injections are an effective and generally well tolerated, minimally invasive option for the treatment of moderate to severe SMF in select adults.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Kythera Biopharmaceuticals Inc. ATX-101 (deoxycholic acid) injection: Advisory Committee Briefing Materials: available for public release. 2015. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed 17 Oct 2016.

  2. Honigman R, Castle DJ. Aging and cosmetic enhancement. Clin Interv Aging. 2006;1(2):115–9.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Schlessinger J, Weiss SR, Jewell M, et al. Perceptions and practices in submental fat treatment: a survey of physicians and patients. Skinmed. 2013;11(1):27–31.

    PubMed  Google Scholar 

  4. Koehler J. Complications of neck liposuction and submentoplasty. Oral Maxillofac Surg Clin North Am. 2009;21(1):43–52, vi.

  5. Patel BC. Aesthetic surgery of the aging neck: options and techniques. Orbit. 2006;25(4):327–56.

    Article  PubMed  Google Scholar 

  6. Petrou I. Minimally invasive submental fat reduction proves successful. 2011. http://cosmeticsurgerytimes.modernmedicine.com. Accessed 17 Oct 2016.

  7. Rotunda AM, Suzuki H, Moy RL, et al. Detergent effects of sodium deoxycholate are a major feature of an injectable phosphatidylcholine formulation used for localized fat dissolution. Dermatol Surg. 2004;30(7):1001–8.

    PubMed  Google Scholar 

  8. de Aguiar Vallim TQ, Tarling EJ, Edwards PA. Pleiotropic roles of bile acids in metabolism. Cell Metab. 2013;17(5):657–69.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  9. Kythera Biopharmaceuticals Inc. Kybella™ (deoxycholic acid) injection, for subcutaneous use: US prescribing information. 2015. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed 17 Oct 2016.

  10. Kythera Biopharmaceuticals (Europe) Ltd. Belkyra 10 mg/ml solution for injection: EU summary of product characteristics. 2016. http://mri.medagencies.org/Human/Product/Details/48055. Accessed 17 Oct 2016.

  11. Thuangtong R, Bentow JJ, Knopp K, et al. Tissue-selective effects of injected deoxycholate. Dermatol Surg. 2010;36(6):899–908.

    Article  CAS  PubMed  Google Scholar 

  12. Dover J, Schlessinger J, Young L, et al. Reduction of submental fat with ATX-101: results from a phase IIB study using investigator, subject, and magnetic resonance imaging assessments [abstract no. 4787]. J Am Acad Dermatol. 2012;66(4 Suppl. 1):AB29.

  13. Ogden S, Griffiths T. A novel injectable drug for the reduction of localized fat. Br J Dermatol. 2011;165:98–9.

    Article  CAS  Google Scholar 

  14. Rzany B, Griffiths T, Walker P, et al. Reduction of unwanted submental fat with ATX-101 (deoxycholic acid), an adipocytolytic injectable treatment: results from a phase III, randomized, placebo-controlled study. Br J Dermatol. 2014;170(2):445–53.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  15. Ascher B, Hoffmann K, Walker P, et al. Efficacy, patient-reported outcomes and safety profile of ATX-101 (deoxycholic acid), an injectable drug for the reduction of unwanted submental fat: results from a phase III, randomized, placebo-controlled study. J Eur Acad Dermatol Venereol. 2014;28(12):1707–15.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  16. Walker P, Lee D. A phase 1 pharmacokinetic study of ATX-101: serum lipids and adipokines following synthetic deoxycholic acid injections. J Cosmet Dermatol. 2015;14(1):33–9.

    Article  PubMed  Google Scholar 

  17. Walker P, Fellmann J, Lizzul PF. A phase I safety and pharmacokinetic study of ATX-101: injectable, synthetic deoxycholic acid for submental contouring. J Drugs Dermatol. 2015;14(3):279–87.

    CAS  PubMed  Google Scholar 

  18. Jones DH, Carruthers J, Joseph JH, et al. REFINE-1, a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial with ATX-101, an injectable drug for submental fat reduction. Dermatol Surg. 2016;42(1):38–49.

    Article  CAS  PubMed  Google Scholar 

  19. Humphrey S, Sykes J, Kantor J, et al. ATX-101 for reduction of submental fat: a phase III randomized controlled trial. J Am Acad Dermatol. 2016;75(4):788–97.

    Article  CAS  PubMed  Google Scholar 

  20. US National Institutes of Health. ClinicalTrials.gov identifiers NCT01542034 and NCT01546142. 2014. http://www.clinicaltrials.gov. Accessed 15 Aug 2016.

  21. Bhatia AC, Dayan SH, Hoffmann K, et al. Reductions in submental fat achieved with deoxycholic acid injection (ATX-101) are maintained over time: results from long-term, follow-up studies [abstract]. In: American Society for Dermatologic Surgery Annual Meeting; 2015.

  22. Dayan SH, Jones DH, Carruthers J, et al. A pooled analysis of the safety and efficacy results of the multicenter, double-blind, randomized, placebo-controlled phase 3 REFINE-1 and REFINE-2 trials of ATX-101, a submental contouring injectable drug for the reduction of submental fat [abstract no. 25542]. In: American Society of Plastic Surgeons: Plastic Surgery The Meeting; 2014.

  23. Beer K, Donofrio L, Gross TM, et al. Clinically meaningful reduction in submental fat during and after treatment with ATX-101 in the US/CAN phase 3 trials, REFINE-1 and REFINE-2 [oral presentation 1294]. In: American Academy of Dermatology Annual Meeting; 2015.

  24. Monheit GD, Humphrey S, Joseph JH, et al. Assessing the psychological and visual impact of submental fat using a validated questionnaire (Patient-Reported Submental Fat Impact Scale): result of a pooled analysis from the REFINE trials [abstract]. In: American Society for Dermatologic Surgery Annual Meeting; 2015.

  25. Brandt FS, Maas C, Lizzul PF, et al. Efficacy of ATX-101 for reducing submental fullness associated with submental fat in demographic subgroups of subjects from the US/CAN phase 3 trials, REFINE-1 and REFINE-2 [oral presentation no. 1284]. In: American Academy of Dermatology Annual Meeting; 2015.

  26. McDiarmid J, Ruiz JB, Lee D, et al. Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic reduction of excess submental fat. Aesthetic Plast Surg. 2014;38(5):849–60.

    Article  PubMed  PubMed Central  Google Scholar 

  27. Global Education Group and MedEdicus LLC. Achieving total facial rejuvenation with submental contouring: current and emerging strategies [CME Educational Session]. In: American Society for Dermatologic Surgery Annual Meeting; 2014.

  28. Dulguerov N, D’Souza A. Update on treatment rationale and options for the ageing face. Curr Opin Otolaryngol Head Neck Surg. 2011;19(4):269–75.

    Article  PubMed  Google Scholar 

  29. Beer K, Callender V, Fagien S, et al. The condition of submental fullness and treatment outcomes registry (CONTOUR): a non-interventional study of submental fullness, treatment options administered, and associated outcomes [abstract]. In: American Society for Dermatologic Surgery Annual Meeting; 2015.

Download references

Acknowledgements

During the peer review process, the manufacturer of deoxycholic acid was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

Author information

Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Emma D. Deeks

Authors
  1. Emma D. Deeks
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Emma D. Deeks.

Ethics declarations

Funding

The preparation of this review was not supported by any external funding.

Conflict of interest

Emma Deeks is a salaried employee of Adis/Springer, is responsible for the article content and declares no conflicts of interest.

Additional information

The manuscript was reviewed by: A. A. Aboud, King Abdullah Medical City, Makkah, Kingdom of Saudi Arabia; C. W. Hanke, Laser and Skin Surgery Center of Indiana, Carmel, IN, USA; J. M. Stuzin, University of Miami School of Medicine, Miami, FL, USA; U. Wollina, Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Deeks, E.D. Deoxycholic Acid: A Review in Submental Fat Contouring. Am J Clin Dermatol 17, 701–707 (2016). https://doi.org/10.1007/s40257-016-0231-3

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40257-016-0231-3

Keywords

Search

Navigation