Kybella With Triamcinolone
Condition: Adiposity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This is a two-site randomized, double-blind comparison trial of Kybella(TM) injections with
      or without triamcinolone acetate for the reduction of submental fat. 30 subjects will be
      enrolled into the trial (15 subjects per site). At each site, 5 will be randomized to receive
      Kybella(TM) injections alone whereas 10 will receive Kybella(TM) plus differing doses of
      triamcinolone acetate in the following way:

        1. Group 1 (5 patients per site): 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.

        2. Group 2 (10 patients per site): 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

      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. No lidocaine will be injected prior to injections to prevent further dilution
      of injected Kybella™ as it will be premixed with Kybella™. Chilling with cold will be the
      method of pain reduction for needle insertion.

      Canfield Vectra 3D imaging will be performed at baseline and final visit (Appendix C) with
      analysis and calculation of volumetric changes performed at baseline and final visit. Photos
      will also be taken with the Intellistudio at all other visits. 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): Injectable sodium deoxycholate; Injectable sodium deoxycholate with Triamcinolone acetate
Intervention type(s): Drug; Combination Product
Intervention description(s): 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
Other intervention name(s): Kybella; Kybella with Triamcinolone Acetate
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Deoxycholic Acid; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 10 subjects will be part of a control group treated without triamcinolone and 20 subjects will be treated with triamcinolone.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment