Patients were randomized into two treatment arms and instructed to apply 1 g of either verum- (active ingredient: calcipotriol 0.05 µg/g) or placebo-containing ointment topically onto two designated target wounds (≥ 6 cm2 each) daily over a period of four weeks. No other changes to standard of care of the patients were applied. Thus, while patients were instructed not to apply any other topical substances onto the designated target wounds, all other EB lesions were continued to be concurrently treated with the previous local wound dressings.
After a two-month wash out-phase, patients crossed over into the other treatment arm. Wounds were photographed, measured and swabbed for microbiome profiling at study visits (V) on day 0 (V1/V4), 14 (V2/V5) and 28 (V3/V6) during each treatment period.
Blood drawing was optional for the patient and was performed at the beginning and end of each treatment phase to assess serum calcium levels.
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