Ann: Botanix Announces BTX 1503 Data and Progression to Phase 3, page-144

In a phase II clinical trial, all the volunteers usually get the same dose. But some phase II studies randomly assign participants to different treatment groups (much like what’s done in phase III trials). These groups may get different doses or get the treatment in different ways to see which provides the best balance of safety and effectiveness.

No placebo (sham or inactive treatments) is used.

The primary endpoint for the Phase 2 Study measured an absolute change from baseline in inflammatory lesions at week 12.

The primary endpoint, all dose groups of BTX 1503 reduced the number of inflammatory lesions from baseline with the highest efficacy obtained for the 5% BTX 1503 QD group (-11.8 lesions). This corresponds to an average percent reduction of 40.54%.

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