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Background  Unwanted submental fat ( SMF ) may result in an unattractive chin profile and dissatisfaction with appearance. An approved and rigorously tested non‐surgical method for  SMF  reduction is lacking.    Objective  To evaluate the efficacy and safety of  ATX ‐101 for the pharmacological reduction of unwanted  SMF  in a phase  III  randomized, double‐blind, placebo‐controlled study.    Methods  Patients ( n  = 360) with moderate or severe  SMF  were randomized to receive  ATX ‐101 1 or 2 mg/cm 2  or placebo injected into their  SMF  for up to four treatments ~28 days apart, with a 12‐week follow‐up. Coprimary efficacy endpoints were the proportions of treatment responders, defined as a ≥1‐point reduction in  SMF  on the Clinician‐Reported Submental Fat Rating Scale ( CR ‐ SMFRS ), and those satisfied with their appearance in association with their face and chin after treatment on the Subject Self‐Rating Scale ( SSRS  score ≥4). Secondary efficacy endpoints included a ≥1‐point improvement in  SMF  on the Patient‐Reported Submental Fat Rating Scale ( PR ‐ SMFRS ) and changes in the Patient‐Reported Submental Fat Impact Scale ( PR ‐ SMFIS ). Additional patient‐reported outcomes and changes in the Skin Laxity Rating Scale were recorded. Adverse events (AEs) and laboratory test results were monitored.    Results  Compared with placebo, a greater proportion of patients treated with  ATX ‐101 1 and 2 mg/cm 2  showed a ≥1‐point improvement in  CR ‐ SMFRS  (58.3% and 62.3%, respectively, vs. 34.5% with placebo;  P  < 0.001) and patient satisfaction ( SSRS  score ≥4) with the appearance of their face and chin (68.3% and 64.8%, respectively, vs. 29.3%;  P  < 0.001). Patient‐reported secondary efficacy endpoints showed significant improvements in  SMF  severity ( PR ‐ SMFRS ;  P  = 0.009 for  ATX ‐101 1 mg/cm 2 ,  P  < 0.001 for  ATX ‐101 2 mg/cm 2  vs. placebo) and emotions and perceived self‐image ( PR ‐ SMFIS ;  P  < 0.001). No overall worsening of skin laxity was observed. AEs were mostly transient, mild to moderate in intensity and localized to the treatment area.    Conclusion   ATX ‐101 was effective and well tolerated, and may be an alternative to surgery for patients desiring improvement of their submental profile.

journal of the european academy of dermatology and venereology

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