Kybella With Triamcinolone

NCT03361176 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Kybelladose-2017-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Adiposity

Outcome Measures

Primary Outcomes (1)

• Change in Clinician-Reported Submental Fat Rating Scale

  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)

  90 Days from Baseline

Secondary Outcomes (2)

• Change in Clinician-Reported Submental Laxity Rating Scale

  90 days from baseline

• Subject Satisfaction Rating Scale

  Post-treatment to Day 180

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

Drug: Injectable sodium deoxycholate

w/ Triamcinolone

EXPERIMENTAL

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.

Combination Product: Injectable sodium deoxycholate with Triamcinolone acetate

Interventions

Injectable sodium deoxycholate DRUG

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.

Also known as: Kybella

Control

Injectable sodium deoxycholate with Triamcinolone acetate COMBINATION_PRODUCT

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

Also known as: Kybella with Triamcinolone Acetate

w/ Triamcinolone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead
• Allergan: collaborator
• Maryland Laser Skin and Vein Institute: collaborator

Study Sites (2)

West Dermatology Research Center

San Diego, California, 92121, United States

Location

Maryland Dermatology Laser, Skin and Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Deoxycholic Acid; Triamcinolone

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes; Pregnadienes; Pregnanes; Steroids, Fluorinated

Results Point of Contact

• Title: Robert A. Weiss, MD
• Organization: Maryland Laser Skin and Vein

cmyers@mdlsv.com

4106662839

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and Outcomes Assessors will be blinded to the treatment arms subjects are randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 10 subjects will be part of a control group treated without triamcinolone and 20 subjects will be treated with triamcinolone.

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 4, 2017
• Study Start: March 26, 2018
• Primary Completion: October 12, 2018
• Study Completion: December 18, 2018
• Last Updated: May 9, 2019
• Results First Posted: May 9, 2019

Record last verified: 2019-05

Locations

US (2)