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

Shannon Humphrey, Jonathan M Sykes, Jonathan Kantor, Vince Bertucci, Patricia Walker, Daniel R. Lee, Paul F. Lizzul, Todd M. Gross, Frederick C. Beddingfield

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

Background 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.

Original languageEnglish (US)
Pages (from-to)788-797.e7
JournalJournal of the American Academy of Dermatology
Volume75
Issue number4
DOIs
StatePublished - Oct 1 2016

Fingerprint

Randomized Controlled Trials
Fats
Placebos
Odds Ratio
Confidence Intervals
Psychology
Injections
Deoxycholic Acid
Therapeutics
Magnetic Resonance Spectroscopy
Magnetic Resonance Imaging
Safety

Keywords

  • aesthetics
  • ATX-101
  • contouring
  • deoxycholic acid
  • efficacy
  • injectable
  • minimally invasive
  • nonsurgical
  • safety
  • submental fat

ASJC Scopus subject areas

  • Dermatology

Cite this

ATX-101 for reduction of submental fat : A phase III randomized controlled trial. / Humphrey, Shannon; Sykes, Jonathan M; Kantor, Jonathan; Bertucci, Vince; Walker, Patricia; Lee, Daniel R.; Lizzul, Paul F.; Gross, Todd M.; Beddingfield, Frederick C.

In: Journal of the American Academy of Dermatology, Vol. 75, No. 4, 01.10.2016, p. 788-797.e7.

Research output: Contribution to journalArticle

Humphrey, S, Sykes, JM, Kantor, J, Bertucci, V, Walker, P, Lee, DR, Lizzul, PF, Gross, TM & Beddingfield, FC 2016, 'ATX-101 for reduction of submental fat: A phase III randomized controlled trial', Journal of the American Academy of Dermatology, vol. 75, no. 4, pp. 788-797.e7. https://doi.org/10.1016/j.jaad.2016.04.028
Humphrey, Shannon ; Sykes, Jonathan M ; Kantor, Jonathan ; Bertucci, Vince ; Walker, Patricia ; Lee, Daniel R. ; Lizzul, Paul F. ; Gross, Todd M. ; Beddingfield, Frederick C. / ATX-101 for reduction of submental fat : A phase III randomized controlled trial. In: Journal of the American Academy of Dermatology. 2016 ; Vol. 75, No. 4. pp. 788-797.e7.
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abstract = "Background 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.",
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AU - Humphrey, Shannon

AU - Sykes, Jonathan M

AU - Kantor, Jonathan

AU - Bertucci, Vince

AU - Walker, Patricia

AU - Lee, Daniel R.

AU - Lizzul, Paul F.

AU - Gross, Todd M.

AU - Beddingfield, Frederick C.

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N2 - Background 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.

AB - Background 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.

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KW - contouring

KW - deoxycholic acid

KW - efficacy

KW - injectable

KW - minimally invasive

KW - nonsurgical

KW - safety

KW - submental fat

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