ATX-101 for reduction of submental fat: A phase III randomized controlled trial

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• 作者：Shannon Humphrey ; MD^a ; ^b ; ^{shannon@carruthers-humphrey.com" class="auth_mail" title="E-mail the corresponding author} ; Jonathan Sykes ; MD^c ; Jonathan Kantor ; MD ; MSCE ; MA^d ; ^e ; Vince Bertucci ; MD^f ; ^g ; Patricia Walker ; MD ; PhD^h ; Daniel R. Lee ; MS^h ; Paul F. Lizzul ; MD ; PhD ; MPH ; MBA^h ; Todd M. Gross ; PhD^h ; Frederick C. Beddingfield III ; MD ; PhD^h ; ⁱ
• 关键词：aesthetics ; ATX-101 ; contouring ; deoxycholic acid ; efficacy ; injectable ; minimally invasive ; nonsurgical ; safety ; submental fat
• 刊名：Journal of the American Academy of Dermatology
• 出版年：2016
• 出版时间：October 2016
• 年：2016
• 卷：75
• 期：4
• 页码：788-797.e7
• 全文大小：3233 K

文摘

ATX-101, an injectable form of deoxycholic acid, causes adipocytolysis when injected subcutaneously into fat.

Objective

We sought to evaluate the efficacy and safety of ATX-101.

Methods

In this phase III trial (REFINE-2), adults dissatisfied with their moderate or severe submental fat (SMF) were randomized to ATX-101 or placebo. Coprimary end points, evaluated at 12 weeks after last treatment, were composite improvements of 1 or more grades and 2 or more grades in SMF observed on both the validated Clinician- and Patient-Reported SMF Rating Scales. Other end points included magnetic resonance imaging–based assessment of submental volume, assessment of psychological impact of SMF, and additional patient-reported outcomes.

Results

Among those treated with ATX-101 or placebo (n = 258/treatment group), 66.5% versus 22.2%, respectively, achieved a composite improvement of 1 or more grades (Mantel-Haenszel risk ratio 2.98; 95% confidence interval 2.31-3.85) and 18.6% versus 3.0% achieved a composite improvement of 2 or more grades in SMF (Mantel-Haenszel risk ratio 6.27; 95% confidence interval 2.91-13.52; P < .001 for both). Those treated with ATX-101 were more likely to achieve submental volume reduction confirmed by magnetic resonance imaging, greater reduction in psychological impact of SMF, and satisfaction with treatment (P < .001 for all). Overall, 85.7% of adverse events in the ATX-101 group and 76.9% in the placebo group were localized to the injection site.

Limitations

Follow-up was limited to 44 weeks.

Conclusion

ATX-101 is an alternative treatment for SMF reduction.