At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Dose-ranging Trial of Subcutaneous Sodium Deoxycholate Injections With or Without Low Dose Triamcinolone and Low Dose Lidocaine for Reduction of Submental Fat With Reduction of Pain and Swelling
In Brief
A Phase 4 clinical trial evaluating Injectable sodium deoxycholate and Injectable sodium deoxycholate with Triamcinolone acetate for Adiposity. Completed, enrolled 30 participants across 2 sites.
Detailed Summary
This study is to evaluate the efficacy, edema and pain associated with Kybella(TM) injections of the upper neck in the treatment of submental fat with varying low concentrations of triamcinolone acetonide plus low doses of lidocaine.
Study Details
Timeline
Interventions
Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline to the non-TMC group to maintain equal concentrations in each injection so that the final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point will be delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total maximal dose of up to 100 mg of SDOC.
Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate, 0.2 mL of 1% lidocaine with no epinephrine and then delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total dose of up to 100 mg of SDOC using a 30 gauge (or smaller) 0.5-inch needle. The final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point