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Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat

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ClinicalTrials.gov Identifier: NCT03241563
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Goldman, Butterwick, Fitzpatrick and Groff

Tracking Information
First Submitted Date  ICMJE March 2, 2017
First Posted Date  ICMJE August 7, 2017
Last Update Posted Date August 7, 2017
Study Start Date  ICMJE April 2016
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2017)
Evaluation of Efficacy of Kybella with Triamcinolone in the Reduction of Submental Fat [ Time Frame: 6 Months ]
evaluate the efficacy associated with Kybella injections for the reduction of fat of the upper neck in the treatment of submental fat with and without added triamcinolone acetonide. An evaluator blinded to the study will grade the level of improvement of the submental fat using the Clinician Graded Submental Fat Rating Scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2017)
Evaluation of Safety of Kybella with Triamcinolone for Reduction of Submental Fat [ Time Frame: 6 months ]
Differences in rates of edema, erythema, tenderness, and erosion/ulceration, based on blinded evaluator assessment, will be compared between subjects treated with Kybella with and without triamcinolone
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat
Official Title  ICMJE A Randomized, Double-blind Comparison Trial of Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat
Brief Summary

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.

Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. 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.

Detailed Description

This is a Single-site randomized, double-blind comparison trial of Kybella injections with or without triamcinolone acetate for the reduction of submental fat. 20 subjects will be enrolled into the trial. Of these 20 subjects, 5 will be randomized to receive Kybella injections alone whereas 15 will receive Kybella plus triamcinolone acetate in the following way:

  1. Kybella alone: 2 mg/cm2 of Kybella will be 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 sodium deoxycholate.
  2. Kybella plus triamcinolone: 0.2 mL of 2 mg/cm2 of Kybella will be mixed with 0.05 mL of 40 mg/mL of triamcinolone acetate and then delivered in up to 50 injections spaced 1.0 cm apart at 0.25 mL/injection for a total dose of up to 100 mg of sodium deoxycholate using a 30 gauge (or smaller) 0.5-inch needle.

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.

Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fat Reduction
Intervention  ICMJE
  • Drug: Sodium Deoxycholate
    Other Name: Kybella
  • Drug: Triamcinolone
    Triamcinolone 40mg/ml
Study Arms  ICMJE
  • Active Comparator: without triamcinolone
    sodium Deoxycholate without triamcinolone
    Intervention: Drug: Sodium Deoxycholate
  • Active Comparator: with triamcinolone
    sodium Deoxycholate with triamcinolone
    Interventions:
    • Drug: Sodium Deoxycholate
    • Drug: Triamcinolone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2017)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 HIPPA 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03241563
Other Study ID Numbers  ICMJE ATX-TRIAM-2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Goldman, Butterwick, Fitzpatrick and Groff
Study Sponsor  ICMJE Goldman, Butterwick, Fitzpatrick and Groff
Collaborators  ICMJE Allergan
Investigators  ICMJE
Principal Investigator: Mitchel P Goldman, MD DCLA
PRS Account Goldman, Butterwick, Fitzpatrick and Groff
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP