NCT03241563

Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat

A Randomized, Double-blind Comparison Trial of Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The subjects and evaluating investigator will be blinded to the treatment, thus maintaining double-blind status. By nature of the varying volumes of injection, the treating investigator will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced 4 weeks apart. Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. Follow up visits will be performed 3 and 5 days after each injection session to assess for side effect and tolerability profile. After the final injection session, additional follow up visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be recorded at baseline and at end of study.

Detailed description

This is a Single-site randomized, double-blind comparison trial of Kybella injections with or without triamcinolone acetate for the reduction of submental fat. 20 subjects will be enrolled into the trial. Of these 20 subjects, 5 will be randomized to receive Kybella injections alone whereas 15 will receive Kybella plus triamcinolone acetate in the following way: 1. Kybella alone: 2 mg/cm2 of Kybella will be 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 sodium deoxycholate. 2. Kybella plus triamcinolone: 0.2 mL of 2 mg/cm2 of Kybella will be mixed with 0.05 mL of 40 mg/mL of triamcinolone acetate and then delivered in up to 50 injections spaced 1.0 cm apart at 0.25 mL/injection for a total dose of up to 100 mg of sodium deoxycholate using a 30 gauge (or smaller) 0.5-inch needle. The treatment area will be bounded superiorly by a line 1 cm inferior to the mandibular margin, laterally by the sternocleidomastoid muscles, and inferiorly by the hyoid bone. The subjects and evaluating investigator will be blinded to the treatment, thus maintaining double-blind status. By nature of the varying volumes of injection, the treating investigator will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced 4 weeks apart. Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. Follow up visits will be performed 3 and 5 days after each injection session to assess for side effect and tolerability profile. After the final injection session, additional follow up visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be recorded at baseline and at end of study.

Conditions

• Fat Reduction

Interventions

Type	Name	Description
DRUG	Sodium Deoxycholate
DRUG	Triamcinolone	Triamcinolone 40mg/ml

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2017-08-07
• Last updated: 2017-08-07

Locations

1 site across 1 country: United States