RE: FILSUVEZ®3 Sep 2020 09:56
The Amicus phase III trial for EB (also a topical cream) recently published failed results due to a better than expected placebo response, a vehicle cream in this case:
“Results showed that SD-101 failed to show statistically significant improvement in wound healing compared to the vehicle cream. Likewise, no benefits were found in pain or itching.
An analysis found a higher-than-expected placebo response rate in patients given the control cream, which increased over time. Researchers then suggested that lanolin oil and cod liver oil, which were components of the vehicle cream and have known skin healing properties, could have driven the unexpected effects”
My questions are, why would they use a placebo cream with ingredients that have known skin healing properties?!
Am I correct in stating that the placebo cream in the case of Amryt’s AP101 is pure sunflower oil?