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The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema.
Full description
This study evaluated the effects of four interventions, pre- and post-subcutaneous injections of deoxycholic acid injection relative to placebo in adults with submental fullness. Participants were randomized to either deoxycholic acid injection or placebo in a ratio of 4:1 and to one of four patient experience management paradigms.
Participants were required to visit the research facility on 10 separate occasions for protocol-defined treatments, procedures, tests, and observations.
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Interventional model
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84 participants in 8 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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