Kybella With Triamcinolone

Phase 4

Completed

Conditions: Adiposity

Interventions: Drug: Injectable sodium deoxycholate
Combination Product: Injectable sodium deoxycholate with Triamcinolone acetate

Registration Number: NCT03361176

Lead Sponsor: Goldman, Butterwick, Fitzpatrick and Groff

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

Inclusion Criteria

Females or Males in good general health age 18 - 65 years of age
Fitzpatrick skin types I-VI
Must be willing to give and sign a HIPAA form and informed consent form
Must be willing and able to comply with all study protocols and schedules
Must have submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (PR-SMFRS)
Negative urine pregnancy test prior to each treatment (if applicable)
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)
Males must be willing to be clean shaven for all study visits
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

Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial
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
Treatment with botulinum toxin injections in the neck or chin area within 6 months before randomization
Any Scars, unshaven hair, tattoos or jewelry on or near the proposed treatment area
Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study
An active dermatitis or open wound in the proposed treatment area
An active bacterial, fungal, or viral infection in the proposed treatment area
Pre-existing skin condition to the submental region that may confound evaluation or analysis, at investigator discretion
Previously treated with subcutaneous sodium deoxycholate to the submental region
Previously treated with focused ultrasound, radiofrequency, cryolipolysis or liposuction to the submental region within the previous 6 months
Any other laser, light energy device, or chemical peel treatment to the submental region within the previous 3 months
Pre-existing neurological or gastrointestinal condition leading to dysphagia, dysphonia or facial nerve palsy
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
Must not have a planned fat reduction procedure of any variety to the submental region for the duration of the study
Must not have planned significant alterations in diet or physical activity that may result in significant fluctuations in weight
Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Injectable sodium deoxycholate	Control Group (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 delivered in up to 50 injections per treatment session.
w/ Triamcinolone	Injectable sodium deoxycholate with Triamcinolone acetate	Experimental Group (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 and 0.2 mL of 1% lidocaine with no epinephrine delivered in up to 50 injections per treatment session.

Primary Outcome Measures

Name	Time	Method
Change in Clinician-Reported Submental Fat Rating Scale	90 Days from Baseline	Change in efficacy will be measured from Baseline to 90 days post final treatment using a 5-point Clinician-Reported Submental Fat Rating Scale ranging from Absent (score of 0) to Extreme submental convexity (score of 4)

Secondary Outcome Measures

Name	Time	Method
Change in Clinician-Reported Submental Laxity Rating Scale	90 days from baseline	Laxity will be compared between treatment groups at each post-treatment time point through Day 90 using a 5-Point Clinician Evaluation of Side Effects Scale ranging from None (score of 0) to Severe (score of 4).
Subject Satisfaction Rating Scale	Post-treatment to Day 180	Satisfaction will be compared between treatment groups at each post-treatment time point through Day 180 using a 7-point satisfaction scale rating from extremely dissatisfied (score of 0) to extremely satisfied (score of 6).

Trial Locations

Locations (2): West Dermatology Research Center
🇺🇸
San Diego, California, United States
Maryland Dermatology Laser, Skin and Vein Institute
🇺🇸
Hunt Valley, Maryland, United States
West Dermatology Research Center
🇺🇸San Diego, California, United States