Status:
COMPLETED
Kybella With Triamcinolone
Lead Sponsor:
Goldman, Butterwick, Fitzpatrick and Groff
Collaborating Sponsors:
Allergan
Maryland Laser Skin and Vein Institute
Conditions:
Adiposity
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 aceto...
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 t...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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.
Key Trial Info
Start Date :
March 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03361176
Start Date
March 26 2018
End Date
December 18 2018
Last Update
May 9 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
West Dermatology Research Center
San Diego, California, United States, 92121
2
Maryland Dermatology Laser, Skin and Vein Institute
Hunt Valley, Maryland, United States, 21030