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.
Bottom Line: An approved and rigorously tested non-surgical method for SMF reduction is lacking.Adverse events (AEs) and laboratory test results were monitored.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).
Affiliation: Clinic of Aesthetic Surgery IENA, Paris, France.Show MeSH
Related in: MedlinePlus
Mentions: The majority of patients in all treatment groups showed either no change (61.3% and 71.4% for ATX-101 1 mg/cm2 and 2 mg/cm2 groups, respectively, vs. 80.4% for placebo) or an improvement (29.7% and 21.4%, respectively, vs. 13.7%) in skin laxity (SLRS). A significant improvement in PR-SMFRS score relative to baseline at Visit 7 was reported for 64.9% of patients in the ATX-101 1 mg/cm2 group (P = 0.009) and 67.3% of patients in the ATX-101 2 mg/cm2 group (P < 0.001) compared with 44.1% patients receiving placebo (Fig.5). Patients treated with ATX-101 also reported statistically significant improvements at Visit 7 both for each individual PR-SMFIS question (P < 0.001 for each) and across all questions (P < 0.001): patients receiving either of the ATX-101 dosing regimens felt happier as well as less bothered, less self-conscious, less embarrassed, and that they looked less old and less overweight than those who received placebo (Fig.6). Treatment with ATX-101 2 mg/cm2 resulted in a statistically significant increase in improved confidence (P = 0.018), with female patients feeling more feminine and male patients feeling more masculine (P = 0.042), and patients feeling less self-conscious about their chin appearance (P = 0.045), in comparison with patients treated with placebo according to the subject-reported modified DAS 24.