Kybella With Triamcinolone

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 26, 2018

Primary Completion Date

October 12, 2018

Study Completion Date

December 18, 2018

Conditions
Adiposity
Interventions
DRUG

Injectable sodium deoxycholate

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.

COMBINATION_PRODUCT

Injectable sodium deoxycholate with Triamcinolone acetate

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

Trial Locations (2)

21030

Maryland Dermatology Laser, Skin and Vein Institute, Hunt Valley

92121

West Dermatology Research Center, San Diego

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Allergan

INDUSTRY

collaborator

Maryland Laser Skin and Vein Institute

OTHER

lead

Goldman, Butterwick, Fitzpatrick and Groff

OTHER