At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 93 enrolled
Drug / intervention
Deoxycholic Acid +1 moredrug
Likely dose
Deoxycholic Acid 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-blind, Placebo-controlled Safety Study of ATX-101 (Deoxycholic Acid) Injection for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects With Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Grade 1 or CR-SMFRS Grade 4
In Brief
A Phase 3 clinical trial evaluating Deoxycholic Acid and Placebo for Moderate to Severe Convexity of Submental Fat and 2 related conditions. Completed, enrolled 93 participants across 8 sites.
Detailed Summary
The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area in patients with mild or extreme fullness of the submental fat and ratings of 1 or 4.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJan 2014
First PostedJan 2014
Primary CompletionJun 2015
TodayJul 2026
First PostedJan 14, 2014
Enrollment StartJan 1, 2014
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.5 years ago
Interventions
Deoxycholic Aciddrug
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Placebodrug
Phosphate buffered saline placebo for injection.