Kybella With Triamcinolone

• ClinicalTrials.gov Identifier: NCT03361176
• Recruitment Status: Completed
• First Posted: December 4, 2017
• Results First Posted: May 9, 2019
• Last Update Posted: May 9, 2019
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff
• Collaborators: Allergan; Maryland Laser Skin and Vein Institute
• Information provided by (Responsible Party): Goldman, Butterwick, Fitzpatrick and Groff

Tracking Information

• First Submitted Date: November 21, 2017
• First Posted Date: December 4, 2017
• Results First Submitted Date: March 21, 2019
• Results First Posted Date: May 9, 2019
• Last Update Posted Date: May 9, 2019
• Actual Study Start Date: March 26, 2018
• Actual Primary Completion Date: October 12, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 8, 2019)

Change in Clinician-Reported Submental Fat Rating Scale [ Time Frame: 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)

Original Primary Outcome Measures (submitted: November 28, 2017)

Change in Clinician-Reported Submental Fat Rating Scale [ Time Frame: 180 Days from Baseline ]

Change in efficacy will be measured from Baseline to 180 days post final treatment using a 5-point Clinician-Reported Submental Fat Rating Scale ranging from Absent to Extreme submental convexity.

• Change History: Complete list of historical versions of study NCT03361176 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: May 8, 2019)

• Change in Clinician-Reported Submental Laxity Rating Scale [ Time Frame: 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 [ Time Frame: 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).

Original Secondary Outcome Measures (submitted: November 28, 2017)

• Difference in post-treatment Edema between subjects treated with and without Triamcinolone [ Time Frame: Post-treatment to Day 180 ]
  Edema will be compared between treatment groups at each post-treatment time point through Day 180 using a 5-Point Clinician Evaluation of Side Effects Scale ranging from None to Severe.
• Difference in post-treatment Pain between subjects treated with and without Triamcinolone [ Time Frame: Post-treatment to Day 180 ]
  Pain will be compared between treatment groups at each post-treatment time point through Day 180 using a 5-Point Subject Evaluation of Side Effects Scale ranging from None to Severe.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Kybella With Triamcinolone
• Official Title: A Randomized, Double-blind, Dose-ranging Trial of Subcutaneous Sodium Deoxycholate Injections With or Without Low Dose Triamcinolone and Low Dose Lidocaine for Reduction of Submental Fat With Reduction of Pain and Swelling
• 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.

• Study Type: Interventional
• Study Phase: Phase 4

Study Design

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.

Primary Purpose: Treatment

• Condition: Adiposity

Intervention

• Drug: Injectable sodium deoxycholate
  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.
  Other Name: Kybella
• Combination Product: Injectable sodium deoxycholate with Triamcinolone acetate
  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 Name: Kybella with Triamcinolone Acetate

Study Arms

• Active Comparator: Control
  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.
  Intervention: Drug: Injectable sodium deoxycholate
• Experimental: w/ Triamcinolone
  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.
  Intervention: Combination Product: Injectable sodium deoxycholate with Triamcinolone acetate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 28, 2017): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 18, 2018
• Actual Primary Completion Date: October 12, 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03361176
• Other Study ID Numbers: Kybelladose-2017-02
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

• IPD Sharing Statement: Not Provided
• Responsible Party: Goldman, Butterwick, Fitzpatrick and Groff
• Study Sponsor: Goldman, Butterwick, Fitzpatrick and Groff

Collaborators

• Allergan
• Maryland Laser Skin and Vein Institute

• Investigators: Not Provided
• PRS Account: Goldman, Butterwick, Fitzpatrick and Groff
• Verification Date: May 2019