Kybella With Triamcinolone
Condition: Adiposity
MeSH terms: Obesity
Intervention: Injectable sodium deoxycholate; Injectable sodium deoxycholate with Triamcinolone acetate
Intervention description: 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
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Deoxycholic Acid; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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)
Masking description: Participants and Outcomes Assessors will be blinded to the treatment arms subjects are randomized to.
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Females or Males in good general health age 18 - 65 years of age

          2. Fitzpatrick skin types I-VI

          3. Must be willing to give and sign a HIPAA form and informed consent form

          4. Must be willing and able to comply with all study protocols and schedules

          5. Must have submental fat graded by the investigator as 2 or 3 using the
             Clinician-Reported Submental Fat Rating Scale (PR-SMFRS)

          6. Negative urine pregnancy test prior to each treatment (if applicable)

          7. Female patients will be either of non-childbearing potential defined as:

             7.1 Having no uterus 7.2 No menses for at least 12 months. Or; (WOCBP) women of
             childbearing potential must agree to use an effective method of birth control during
             the course of the study, such as: 7.3 Oral contraceptive pill, injection, implant,
             patch, vaginal ring, intrauterine device 7.4 Intrauterine coil 7.5 Bilateral tubal
             ligation 7.6 Barrier method used with an additional form of contraception (e.g.,
             sponge, spermicide or condom) 7.7 Abstinence (If practicing abstinence must agree to
             use barrier method described above (7.6) if becomes sexually active) 7.8 Vasectomized
             partner (must agree to use barrier method described above (7.6) if becomes sexually
             active with unvasectomized partner)

          8. Males must be willing to be clean shaven for all study visits

          9. The patient must have had a stable weight (no fluctuation of >15 pounds in a year),
             diet, and physical activity for the previous 6 months

        Exclusion Criteria:

          1. Pregnancy, currently breast feeding or planning pregnancy for the duration of the
             trial

          2. Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic
             disease is not yet stabilized will not be considered for entry into the study

          3. Treatment with botulinum toxin injections in the neck or chin area within 6 months
             before randomization

          4. Any Scars, unshaven hair, tattoos or jewelry on or near the proposed treatment area

          5. Significant history or current evidence of a medical, psychological or other disorder
             that, in the investigator's opinion, would preclude enrollment into the study

          6. An active dermatitis or open wound in the proposed treatment area

          7. An active bacterial, fungal, or viral infection in the proposed treatment area

          8. Pre-existing skin condition to the submental region that may confound evaluation or
             analysis, at investigator discretion

          9. Previously treated with subcutaneous sodium deoxycholate to the submental region

         10. Previously treated with focused ultrasound, radiofrequency, cryolipolysis or
             liposuction to the submental region within the previous 6 months

         11. Any other laser, light energy device, or chemical peel treatment to the submental
             region within the previous 3 months

         12. Pre-existing neurological or gastrointestinal condition leading to dysphagia,
             dysphonia or facial nerve palsy

         13. Pre-existing medical condition other than increased submental fat that may result in
             increased submental fullness such as but not limited to thyroid enlargement, goiter,
             cervical lymphadenopathy etc., at investigator discretion

         14. Must not have a planned fat reduction procedure of any variety to the submental region
             for the duration of the study

         15. Must not have planned significant alterations in diet or physical activity that may
             result in significant fluctuations in weight

         16. Current participation or participation within 30 days prior to the start of this study
             in a drug or other investigational research study.