Efficacy, patient-reported outcomes and safety profile of ATX-101 (deoxycholic acid), an injectable drug for the reduction of unwanted submental fat: results from a phase III, randomized, placebo-controlled study.
Bottom Line: To evaluate the efficacy and safety of ATX-101 for the pharmacological reduction of unwanted SMF in a phase III randomized, double-blind, placebo-controlled study.Adverse events (AEs) and laboratory test results were monitored.Patient-reported secondary efficacy endpoints showed significant improvements in SMF severity (PR-SMFRS; P = 0.009 for ATX-101 1 mg/cm(2) , P < 0.001 for ATX-101 2 mg/cm(2) vs. placebo) and emotions and perceived self-image (PR-SMFIS; P < 0.001).
Affiliation: Clinic of Aesthetic Surgery IENA, Paris, France.Show MeSH
Related in: MedlinePlus
Mentions: Patients received a maximum of 10 mL of one of two ATX-101 fixed-dose regimens (1 mg/cm2 or 2 mg/cm2) or placebo (sodium phosphate and sodium chloride in water for injection) at up to four treatment sessions with an interval of approximately 28 days between each session (Visits 2–5). During each treatment session, 0.2 mL per injection of either ATX-101 (1 mg/cm2 or 2 mg/cm2) or placebo was injected subcutaneously directly into the SMF, using a grid to position injection sites 1.0 cm apart and achieve an even distribution. Up to 50 individual injections were administered per treatment session. Anaesthesia with topical lidocaine preparations and ice, and in some cases local lidocaine injections, was provided as required. Vital signs were measured at each visit during treatment and follow-up periods. SMF reduction and occurrence of adverse events (AEs) were assessed at each treatment visit. AEs were also assessed at 7 ± 3 days after each treatment visit. All AEs and use of concomitant medications were reported. Treatment could be delayed or stopped for efficacy (early therapeutic success) or safety reasons (occurrence of AEs or insufficient fat to safely administer injections), as well as discontinued at the patient's request. All randomized patients were to receive at least one treatment session and attend a 4-week and a 12-week follow-up visit (Visits 6 and 7) after the final treatment session (Fig.1).