A Study to Evaluate the Efficacy, Safety and Tolerability of CT327 in Atopic Dermatitis
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
This is a Phase II, multi-centre, randomised, double-blind, placebo-controlled study in male
and female subjects, aged ≥ 12 years with mild/moderate atopic dermatitis and at least
moderate pruritus. All subjects will receive BID topical applications of CT327 ointment or
vehicle for up to 4 weeks.
At baseline, the subjects must have atopic dermatitis, as defined by the Hanifin and Rajka
criteria, which involves a minimum of 5% and a maximum of 20% body surface area, an
Investigator Global Assessment Score of 2 or 3 (mild or moderate) and pruritus visual
analogue scale scores of ≥ 40mm (at least moderate).
All subjects will attend a screening visit not more than 21 days prior to Day 1. Subjects
will be required to return to the clinic on Days 1 (baseline visit), 4, 11, 18 and 29 (end of
treatment visit). All subjects will be asked to attend for a follow-up visit 14 (±3) days
after the last dose of study medication.