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

NCT03241563 | Completed Phase 4

• 1 other identifier: ATX-TRIAM-2016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Fat Reduction

Outcome Measures

Primary Outcomes (1)

• Evaluation of Efficacy of Kybella with Triamcinolone in the Reduction of Submental Fat

  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.

  6 Months

Secondary Outcomes (1)

• Evaluation of Safety of Kybella with Triamcinolone for Reduction of Submental Fat

  6 months

Study Arms (2)

without triamcinolone

ACTIVE COMPARATOR

sodium Deoxycholate without triamcinolone

Drug: Sodium Deoxycholate

with triamcinolone

ACTIVE COMPARATOR

sodium Deoxycholate with triamcinolone

Drug: Sodium Deoxycholate; Drug: Triamcinolone

Interventions

Sodium Deoxycholate DRUG

Also known as: Kybella

with triamcinolone; without triamcinolone

Triamcinolone DRUG

Triamcinolone 40mg/ml

with 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 HIPPA 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

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

Study Sites (1)

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

San Diego, California, 92121, United States

Location

MeSH Terms

Interventions

Deoxycholic Acid; Triamcinolone

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mitchel P Goldman, MD

  DCLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: August 7, 2017
• Study Start: April 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 7, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)