BTX 1702 Phase 1b clinical study designThe Phase 1b study will investigate the safety and tolerability of BTX 1702 in adults over an 8-week treatment period. The primary endpoint is a safety and tolerability assessment, along with exploratory endpoints including absolute change and percentage change in inflammatory lesion counts (papules and pustules) from baseline to day 57; change from baseline in the Investigator’s Global Assessment (IGA-PP) scale at days 29 and 57; and reduction of erythema (redness) severity assessments by each patient and investigator. Patients aged 18 to 65 years old are eligible to be enrolled who have moderate to severe papulopustular rosacea and meet the other eligibility and inclusion criteria.
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Imo, it’s a well made design created with easily met end point. It’s been specifically designed for favourable results. Primary end points are safety and tolerability (with some extra’s)
we all already know it’s safe and tolerable (GRAS) by FDA, so this has been designed in advanced so that we can get that big tick by the FDA.
GOOD WORK. Go team
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