I am not certainly about the perfect kind of study.
But I think that with double-dummy study we will be able to compare the new drug against the placebo and every patient enrolled receive both alternatives. The problem is that is maintaining the blinded condition because we need to adjust the dosis. One group will receive a placebo pill and active topic medication and another group will receive an active pill and placebo a topical medication and the third placebo pill and topical medication. My worry is that giving them just a placebo we are depriving them from receiving adequate treatment.
I think that the cross-over won't be effective because the carryover effect. On this phase II, we can't doubt about the drug efficacy.”