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FDA noted that the supposed placebo control was an external healthy comparison group rather than a proper concurrent placebo arm

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Atopic dermatitis is a highly prevalent disease associated with significant disease burden on the patient and caregiver and with multiple studies demonstrating its marked negative impact on quality of life and high economic cost, says Zelma Chiesa Fuxench, MD, an assistant professor of dermatology at the University of Pennsylvania Perelman School of Medicine in Philadelphia