Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat
Condition: Fat Reduction
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Sodium Deoxycholate; Triamcinolone
Intervention type(s): Drug; Drug
Intervention description(s): Triamcinolone 40mg/ml
Other intervention name(s): Kybella
Intervention MeSH terms: Triamcinolone; Deoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment