Reduction of unwanted submental fat with ATX-101 (deoxycholic acid), an adipocytolytic injectable treatment: results from a phase III, randomized, placebo-controlled study.
Bottom Line: To evaluate the efficacy and safety of ATX-101 for the reduction of unwanted SMF.Most adverse events were transient and associated with the treatment area.ATX-101 was effective and well tolerated for nonsurgical SMF reduction.
Affiliation: Division of Evidence-Based Medicine in Dermatology, Charité-Universitätsmedizin, and RZANY & HUND, Privatpraxis und klinisches Studienzentrum für Dermatologie, Berlin, Germany.Show MeSH
Related in: MedlinePlus
Mentions: At 12 weeks after the final treatment, the proportion of treatment responders (≥ 1-point improvement in the 5-point CR-SMFRS) was significantly greater in both ATX-101 groups than in the placebo group, with a trend towards greater efficacy with the higher ATX-101 dose (1 mg cm−2: 59·2%; 2 mg cm−2: 65·3%; placebo: 23·0%; P < 0·001 for both ATX-101 doses vs. placebo). Odds ratios were 4·73 [95% confidence interval (CI) 2·70–8·28] for ATX-101 1 mg cm−2 and 6·21 (95% CI 3·52–10·94) for ATX-101 2 mg cm−2 (Fig.2). The proportion of patients satisfied with the appearance of their face and chin after treatment (score ≥ 4 on the 7-point SSRS) was significantly greater in both ATX-101 groups compared with placebo (53·3% and 66·1%, respectively, vs. 28·7%; P < 0·001 for both ATX-101 doses vs. placebo) (Fig.3). Odds ratios were 2·99 (95% CI 1·74–5·14) for ATX-101 1 mg cm−2 and 5·22 (95% CI 2·99–9·11) for ATX-101 2 mg cm−2, respectively, vs. placebo. According to the predefined confirmatory testing procedure, statistically significant efficacy was achieved for both ATX-101 dose groups (P < 0·001).
Affiliation: Division of Evidence-Based Medicine in Dermatology, Charité-Universitätsmedizin, and RZANY & HUND, Privatpraxis und klinisches Studienzentrum für Dermatologie, Berlin, Germany.