REFINE-1, a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial With ATX-101, an Injectable Drug for Submental Fat Reduction.

@article{Jones2016REFINE1AM,
  title={REFINE-1, a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial With ATX-101, an Injectable Drug for Submental Fat Reduction.},
  author={D. P. Jones and Jean Carruthers and J. Hepsy Joseph and Valerie D. Callender and Patricia Walker and Daniel R. Lee and Meenakshi P Subramanian and Paul F. Lizzul and Todd M Gross and Frederick C. Beddingfield},
  journal={Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]},
  year={2016},
  volume={42 1},
  pages={38-49}
}
BACKGROUND ATX-101, an injectable form of deoxycholic acid, is approved in the United States and Canada for submental fat (SMF) reduction. OBJECTIVE To report results of REFINE-1, a randomized, double-blind, placebo-controlled, Phase 3 trial investigating the efficacy and safety of ATX-101. METHODS Subjects dissatisfied with their moderate or severe SMF received ATX-101 (2 mg/cm) or placebo. Coprimary outcome measures were composite ≥1-grade and ≥2-grade improvements in clinician-assessed… CONTINUE READING
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