The BELMONT study will evaluate the safety, efficacy and duration of three doses of RT002, the labeled dose of the current market leader BOTOX Cosmetic and a placebo control. BELMONT is expected to enroll approximately 250 subjects at up to 10 sites in Canada. The primary endpoints for the study are the investigator's assessment of glabellar line severity at maximum frown at Week 24 and median duration of effect from the date of treatment back to baseline severity.
Patients in the BELMONT study will be randomized one-to-one across five study arms receiving one of three doses of RT002, an active comparator (BOTOX Cosmetic) or placebo. The RT002 doses will be equal to or greater than the labeled doses of commercially available products. Previous RT002 clinical data showed a similar safety profile across escalating doses.
Looks like RVNC is trying to tilt the playing field in its favor by dosing higher than Botox; the higher dosing may increase duration of action. The trial listing is at https://www.clinicaltrials.gov/ct2/show/NCT02303002.
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