Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events

Exclusion Criteria

• •1. Is unable to tolerate subcutaneous injections.
• •2. Has dysfunctional gallbladder activity (e.g., underwent cholecystectomy or cholecystitis).
• •3. Has any systemic disease including but not limited to gastritis or ulcers, renal dysfunction, hypertension, liver disease, glaucoma, diabetes and/or cardiovascular disease.
• •4. Has any contraindications to oral corticosteroids (prednisone), NSAIDs (e.g., Celecoxib) or non-sedative antihistamines (e.g. Zyrtec)
• •5. Has skin laxity (i.e., elastosis, skin crepiness, skin redundancy, skin draping, vertical and/or horizontal skin bands and folds, blunting of cervical mental angle, loss of opposition of skin to underlying neck structures due to skin laxity) that could obscure the evaluation and treatment of SMF.
• •6. Has any scars, unshaven hair, tattoos, facial hair or jewelry on or near the proposed treatment area.
• •7. Has presence of structures or confounding factors that may interfere with assessing SMF such as but not limited to enlarged submandibular salivary and/or parotid glands, micrognanthia, chin implant, soft tissue volume augmentation of chin and/or jawline, pronounced platysmal bands and deep necklace lines or presence of facial jowls that could obscure the evaluation of SMF.
• •8. Has a fat bulge under the chin that is too large to be adequately treated by 32±4 contiguous injections on a 1cm grid .
• •9. Has a fat bulge under the chin that is of an insufficient volume to allow 32±4 injections within a contiguous 1 cm grid.
• •10. Has significant history or current evidence of a medical, psychological or other disorder that, in the Investigator's opinion, would preclude enrollment in the study.
• •11. Has an active bacterial, fungal, or viral infection in the proposed treatment area.
• •12. Has a pre-existing skin condition in the submental region that, at the Investigator's discretion, may confound evaluation or analysis.
• •13. Has previously had treatments or surgery in the submentum, such as but not limited to, focused ultrasound, radiofrequency, cryolipolysis, liposuction, sodium deoxycholate, or neck lift.
• •14. Has pre-existing neurological or gastrointestinal condition leading to dysphagia, dysphonia, or facial nerve palsy.
• •15. Has Dercum's Disease.
• •16. Has allergic reactions to injectables
• •17. Has allergic reactions to Zyrtec or Celecoxib.
• •18. Has any pre-existing medical condition other than increased SMF that, at the Investigator's discretion, may result in increased submental fullness, such as but not limited to, thyroid enlargement, goiter, cervical lymphadenopathy, etc.
• •19. Has a planned fat reduction procedure of any variety to the submental region for the duration of the study.
• •20. Has medication or a history of coagulopathy.
• •21. Has a history or family history of venous thrombotic disease.
• •22. Has been treated chronically at least three (3) months prior to study entry with systemic steroids or immunosuppressive drugs.
• •23. Has been treated chronically at least one (1) week prior to study entry with non-steroidal anti-inflammatory drugs (NSAIDs)
• •24. Has used anticoagulation therapies that may increase bleeding or bruising (i.e., aspirin, ibuprofen/Celecoxib, warfarin, vitamins, and herbal preparations) for seven (7) days prior to treatment.
• •25. .Has had treatment with botulinum toxin injections in the neck or chin area within nine (9) months prior to screening.
• •26. Current participation or participation within three (3) months prior to the start of this study in a drug or other investigational research study.