| Eligibility |
Inclusion Criteria:
For a subject to be eligible for this study, he or she must meet all of the following
criteria:
1. Is a male or female subject between the ages of 18 and 65 years, inclusive.
2. Previously treated with RZL-012 under protocols RZL-012-SMF-SWMTG-P2US-001 or
RZL-012-SMFC-P2US-001 and whose current C-CAT score is 2, 3 or 4
3. Who successfully completed (as in completed the day 84 visit) the
RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001 studies.
4. Has body mass index (BMI) between >22 kg/m2 and <40 kg/m2.
5. Has SMF bulge that is contiguous and can receive between 16 to 36 injections distanced
1 centimeter (cm) from each other according to the injection grid.
6. Has stable weight, with no fluctuation of >5 kg in the past 12 months.
7. If female, is not pregnant or breastfeeding based on the following:
1. agree to the use of highly effective contraceptive methods for at least 2 weeks
before baseline until 4 weeks after the last day of study drug and a negative
serum pregnancy test (ß-hCG) at screening and negative urine pregnancy test at
baseline; or
2. is abstaining
3. is of nonchildbearing potential defined as clinically infertile as the result of
surgical sterilization (hysterectomy, bilateral tubal ligation, and/or bilateral
oophorectomy); or
4. is confirmed postmenopausal status (defined as either having amenorrhea for = 12
consecutive months without another cause or documented serum follicle-stimulating
hormone (FSH) level > 40 mIU/mL or another documented medical condition (e.g.,
was born without a uterus)) NOTE: The following are considered highly effective
contraceptive methods: hormonal oral contraceptives, injectables, and patches;
intrauterine devices; double-barrier methods (synthetic condom, diaphragm, or
cervical cap used with spermicidal foam, cream, or gel); and male partner
sterilization.
8. If male (with or without vasectomy), agree to the use of highly effective
contraceptive methods as listed above in criteria 7 as well as to use a barrier
method, e.g. condom, from study check-in until 7 days after drug injection.
9. Is willing to avoid strenuous exercise for seven (7) days post treatment.
10. Can adhere to the visit schedule and protocol requirements and be available to
complete the study.
11. Is willing and able to sign an Institutional Review Board (IRB) approved informed
consent form (ICF) indicating that they are aware of the investigational nature of the
study.
Exclusion Criteria:
- Subjects must NOT meet any of the following Exclusion criteria to be eligible for
enrollment:
1. Is unable to tolerate subcutaneous injections.
2. Any subject who had any treatment related SAE's or allergic reactions to
treatment in the previous RZL-012 studies.
3. Has any systemic disease including but not limited to gastritis or ulcers, renal
dysfunction, hypertension, liver disease, glaucoma, diabetes and/or
cardiovascular disease, regardless of whether the condition is controlled with
medication.
4. 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.
5. Has any scars, unshaven hair, tattoos, facial hair, or jewelry on or near the
proposed treatment area.
6. 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, micrognathia, 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.
7. Has a fat bulge under the chin that is too large to be adequately treated by 36
contiguous injections on a 1cm grid .
8. Has a fat bulge under the chin that is of an insufficient volume to allow 16
injections within a contiguous 1 cm grid.
9. 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.
10. Has an active bacterial, fungal, or viral infection in the proposed treatment
area.
11. Has a pre-existing skin condition in the submental region that, at the
Investigator's discretion, may confound evaluation or analysis.
12. 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.
13. Has pre-existing neurological or gastrointestinal condition leading to dysphagia,
dysphonia, or facial nerve palsy.
14. Has Dercum's Disease.
15. Has allergic reactions to injectables
16. 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.
17. Has a planned fat reduction procedure of any variety to the submental region for
the duration of the study.
18. Has medication or a history of coagulopathy.
19. Has a history or family history of venous thrombotic disease.
20. Has been treated chronically at least three (3) months prior to study entry with
systemic steroids or immunosuppressive drugs.
21. Has been treated chronically at least one (1) week prior to study entry with
non-steroidal anti-inflammatory drugs (NSAIDs)
22. 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.
23. Has had treatment with botulinum toxin injections in the neck or chin area within
nine (9) months prior to screening.
24. Current participation or participation within three (3) months prior to the start
of this study in a drug or other investigational research study.
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