An Open-label Study That Will Test a Second Treatment Session of RZL-012.
brief summary
This is a Phase 2, open-label study in which subjects seeking further improvement of their SMF will be treated with a second treatment session of RZL-012. The second treatment session will be offered to subjects previously treated with RZL-012 under protocols RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001. Subjects who fully completed either of the trials and whose C-CAT score is 2, 3 or 4 will be eligible to participate in the new trial. For each subject, the study will consist of a screening period, baseline period in which subjects will receive a second treatment session of RZL-012 and a follow-up period. RZL-012 will be administered during a single treatment session via multiple injections into the submental area under the chin. Subjects will thereafter be monitored for safety and efficacy for at least 84 days.
detailed description
Screening Period:
Subjects will be eligible to undergo screening after successful completion of (defined as completion of the day 84 visit) of either RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001 studies. Subjects will undergo screening within 28 days prior 2nd RZL session. During the screening period, subjects will be assessed for study eligibility by evaluation of subjects' SMF using S-CAT, C-CAT, SIQ8, biochemistry blood tests, 2D photography.
Day 0/Baseline:
Subjects will receive a second multi-injection treatment of RZL-012 on Day 0. AEs will be recorded. Subjects will be asked about their pain levels using VAS.
Day 1-Day 84 Follow-Up Period Subjects will return to the site for study visits on Days 1, 7, 28, 56 and 84 for efficacy and safety assessments.
Safety assessments will include vital signs, labs, AEs severity assessment, and treatment area evaluation. Treatment area evaluations will include evaluation of edema, bruising, dysphasia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, pruritus, skin ulceration and necrosis, injury to the marginal mandibular nerve, vascular and nerve injury, and tissue damage to nearby vulnerable anatomic structures. Swelling severity will be assessed as a function of time. Pain will be assessed using the VAS. Concomitant medications will be recorded.
official title
An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of a Second Treatment Session of RZL-012 Into Submental Fat in Subjects Seeking Further Improvement