Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis.
Status:
Terminated
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
The purpose of this Phase Ib study is to investigate the safety, tolerability and
pharmacokinetics of LEO 29102 2,5 mg/g cream when treating atopic dermatitis (AD) lesions
from 10 up to 100% of the body surface area (BSA) twice daily (BID) for 7 days (Cohorts I,
II, III) and from 10% up to 50% of BSA (bid) for 6 weeks (Cohort IV). This trial will be
performed in four cohorts. Cohort I, II and III includes patients with a larger BSA that
increases from one cohort to the next. After each cohort (Cohort I, II)a blinded evaluation
of the safety and tolerability data will assess whether a stepwise increase in the percentage
of "to be treated BSA" is justified. Cohort IV will start dosing after finalisation of Cohort
II and after submission of data from Cohort I and II to the national authority and IEC for
review.