Kybella With Triamcinolone

• Status: Completed
• Trial end date: 2018-12-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Goldman, Butterwick, Fitzpatrick and Groff
• Collaborators: Allergan; Maryland Laser Skin and Vein Institute
• Treatments: Deoxycholic Acid; Epinephrine; Epinephryl borate; Lidocaine; Racepinephrine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

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.