Mobile health technologies in an interventional hybrid study on actinic keratosis: Results from an early phase randomized controlled trial investigating the safety and efficacy of a cytosolic phospholipase A2 inhibitor gel in photodamaged skin
Vinzent Kevin Ortner,
Kim Kilov,
Alejandro Castillo Mondragón
et al.
Abstract:Hybrid trials are a new trend in dermatological research that leverage mobile health technologies to decentralize a subset of clinical trial elements and thereby reduce the number of in‐clinic visits. In a Phase I/IIa randomized controlled hybrid trial, the safety and efficacy of an anti‐proliferative and anti‐inflammatory drug inhibiting cytosolic phospholipase A2 (AVX001) was tested using 1%, 3% or vehicle gel in 60 patients with actinic keratosis (AK) and assessed in‐clinic as well as remotely. Over the cou… Show more
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