Prospective, Randomized, Double Blind Comparative Study on the Use of Two Creams in Xerosis Atopic Probands
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
Summary
Atopic dermatitis (AD), a chronic and relapsing inflammatory skin disease, is associated with
elevated IgE levels and Th2 responses. It is currently believed that non-pathogenic bacteria
modulate intestinal immune responses avoiding the development of allergic diseases. However,
effects of oral probiotics on AD could not be reproduced in all studies and direct
immuno-modulation of the skin associated immune response by non-pathogenic bacteria has not
been investigated so far. We therefore performed a double blind placebo controlled clinical
study on the effects of an ointment containing 5% extracts of the non-pathogenic bacteria
Vitreoscilla filiformis on AD. Seventy-five AD patients (6-70 years of age) were randomized
to receive either Vitreoscilla filiformis ointment 5% or vehicle ointment daily for 30 days.
Efficacy evaluations, including the "Score of Atopic Dermatitis" (SCORAD), transepidermal
water loss, assessement of microflora, and the patient assessment of itch and loss of sleep
occurred at baseline, day 15, and day 29.