title: Management of Patient Experience With ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat.
abstract: BACKGROUND
  ATX-101 (deoxycholic acid injection; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) was recently approved for submental fat (SMF) reduction in the United States (Kybella) and Canada (Belkyra). The pivotal trials supporting these approvals revealed that ATX-101 is associated with common injection-site treatment reactions consistent with its mechanism of action and administration procedure.
  
  
  OBJECTIVE
  The purpose of this study was to evaluate 4 patient experience management paradigms targeting the common injection-site adverse events of pain, swelling/edema, and bruising after a single treatment session with ATX-101.
  
  
  METHODS
  In this double-blind, parallel-group, exploratory Phase 3b study (ClinicalTrials.gov identifier: NCT02007434), subjects with moderate to severe SMF were randomized 4:1 within each paradigm to receive ATX-101 2 mg/cm or placebo. In Paradigm 1, subjects received a cold pack application to the treatment area. In Paradigm 2, in addition to cold pack application, subjects were treated with topical lidocaine and injectable lidocaine containing epinephrine. In Paradigm 3, in addition to the interventions of Paradigm 2, subjects received loratadine and ibuprofen. Subjects in Paradigm 4 received the same interventions in Paradigm 3, plus application of a chin strap.
  
  
  RESULTS
  Eighty-three subjects were treated. In ATX-101-treated subjects, peak pain occurred within 1 to 5 minutes of treatment, with median values at these time points ranging from 21.4 to 35.7 mm on a 100-mm pain visual analog scale ("mild"). Pain ratings reduced substantially by 15 minutes; at 4 hours after injection, pain was characterized as mild tenderness or mild achiness. Compared with cold alone, treatment with topical and injectable lidocaine reduced median peak pain by 17%. Addition of ibuprofen and loratadine resulted in a total reduction in pain by 40%. Peak swelling/edema in ATX-101-treated subjects was "modest," with mean values ≤1.7 (on a 0-5 scale) across all paradigms. Swelling/edema was not substantially mitigated by the interventions, including ibuprofen, loratidine, and the use of a chin strap. Bruising associated with ATX-101 treatment was confined to the treatment area, with mean values between 1.0 and 1.4 on a 0-to-5 scale. Bruising was modestly reduced by injectable lidocaine with epinephrine.
  
  
  CONCLUSIONS
  Results from this study support the safety of ATX-101 for SMF reduction, and demonstrate that pain and bruising associated with ATX-101 treatment can be mitigated by a series of simple measures.
authors: *SkinCare Physicians, Chestnut Hill, Massachusetts; †Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, Texas; ‡Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada; §Allergan plc, Irvine, California; ‖Evidence Scientific Solutions, Philadelphia, Pennsylvania; ¶Department of Dermatology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California. Drs. Lizzul, Gross, and Beddingfield are former employees of Allergan plc. Current affiliation for Drs. Lizzul and Beddingfield is Sienna Biopharmaceuticals, Inc., Westlake Village, California. Current affiliation for Dr. Gross is Department of Statistics and Applied Probability, University of California Santa Barbara, Santa Barbara, California.
authors: Jeffrey S
authors: JS
authors: Dover
authors: Jeffrey M
authors: JM
authors: Kenkel
authors: Alastair
authors: A
authors: Carruthers
authors: Paul F
authors: PF
authors: Lizzul
authors: Todd M
authors: TM
authors: Gross
authors: Meenakshi
authors: M
authors: Subramanian
authors: Frederick C
authors: FC
authors: Beddingfield
mesh_terms: D000328:Adult; D002680:Chin; D003288:Contusions / Q000209:etiology / Q000628:therapy; D003357:Cosmetic Techniques / Q000009:adverse effects; D003840:Deoxycholic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004487:Edema / Q000209:etiology / Q000628:therapy; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000209:etiology / Q000628:therapy; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control / Q000628:therapy; D050151:Subcutaneous Fat / Q000187:drug effects*
chemical_list: C000599116:ATX-101 compound; D003879:Dermatologic Agents; D003840:Deoxycholic Acid