The Use of Deoxycholic Acid for the Clinical Reduction of Excess Submental Fat in Indian Patients

March 2019 | Volume 18 | Issue 3 | Original Article | 266 | Copyright © 2019

Debraj Shome MD FRCS, FACS, MBAa Stuti Khare MD,b Rinky Kapoor MDc

aDepartment of Facial Plastic Surgery, The Esthetic Clinics, Mumbai, India bCosmetic Dermatology and Dermato-Surgery, The Esthetic Clinics, India cDepartment of Dermatology, Cosmetic Dermatology and Dermato-Surgery; The Esthetic Clinics, India

Abstract

Copy: The injectable adipocytolytic drug deoxycholic acid (DCA) is the first pharmacological intervention approved for the reduction of submental fat (SMF) and offers an alternative to invasive measures to improve the submental profile and the cervico-mental angle. DCA injection (ATX-101, Kybella [United States], Belkyra [Canada]; Kythera Biopharmaceuticals, Inc., Westlake Village, CA, acquired by Allergan, Inc.), are proprietary formulations of synthetically derived DCA that is FDA approved for improvement in the appearance of moderate to severe convexity or fullness associated with SMF.

Aim: As none of the aforementioned are available in India, we undertook this study to study the efficacy of generic DCA for SMF reduction in Indian patients.

Methods: 50 patients with confirmed Indian ethnicity and unwanted SMF were injected 3 mg/cm2 of generic DCA into their SMF, with a 12-week follow-up period. In each session, 5 ml of 30 mg /ml DCA was injected. The sessions were spaced approximately 2 months apart. All these patients with reductions in SMF were reported using Clinician Reported SMF Rating Scale (CR-SMFRS) and Patient Reported SMF Rating Scale (PR-SMFRS) using the Validated Rating Scale for improvement in the appearance of their chin, the neck, and the cervico-mental profile. Also, for objective assessment of improvement in SMF, caliper measurements were used.

Results: One session was required in 2 patients, 12 patients needed 2 sessions, 32 patients needed 3 sessions, and 4 patients needed 4 sessions. Altogether, 90% patients showed at least a decrease of 1 point in (CR-SMFRS). Reduction in SMF as confirmed by caliper measurements was statistically significant.

Conclusion: The findings show generic deoxycholic acid to be equally effective in the treatment for SMF in Indian patients.

J Drugs Dermatol. 2019;18(3):266-272.

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BACKGROUND

Facial aesthetic surgical procedures such as face and neck lifts are consistently amongst the top 5 cosmetic surgical procedures performed annually.Among such procedures, neck contouring is gaining popularity, and various novel technologies (Ultherapy, Merz Aesthetics, Merz North America; CoolMini, ZELTIQ Aesthetics, Pleasanton, CA; Thermi, Almirall Company, S.A.) are available to target this anatomic region.Consequently, interest in rejuvenation strategies for the lower third of the face has surged, and patients increasingly are seeking ways to reduce submental fullness.1Submental fat is considered aesthetically unappealing and can have a negative psychological impact on patients. Accumulated fat deposits treated invasively with surgery liposuction etc., can be associated with serious complications and substantial recovery times, evidence supporting effectiveness of noninvasive energy devices is also limited.2 Lipolytic injectables (injection lipolysis, mesotherapy, or lipodissolve) are minimally invasive, alternative approaches for reducing accumulated submental fat, wherein one or more compounds are injected into the submental fat.3Amongst them, deoxycholic acid (DCA), a naturally occurring bile acid, emulsifies fat for absorption in the intestine with nonselective cell-lysis ability and acts by irreversibly disrupting the adipocyte membrane causing adipocytolysis.4 DCA injections ATX-101, Kybella® in the United States and Belkyra™ in Canada (Kythera Biopharmaceuticals, Inc., Westlake Village, CA, USA, an affiliate of Allergan, Dublin, Ireland) are proprietary formulations of synthetically derived DCA that is FDA approved for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat.5The efficacy and safety of DCA injections in the submental fat area was demonstrated in four phase 3 randomized controlled trials.4, 6, 7 ,8DCA has a nonselective cell-lysis ability, however, affinity is lower in proteinaceous tissues versus fatty tissue. Therefore,

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