An Investigator-initiated Study of Apremilast to Demonstrate Efficacy Nummular Eczema
Status:
Completed
Trial end date:
2021-09-15
Target enrollment:
Participant gender:
Summary
This is an investigator-initiated, single-center, prospective, randomized, double-blind,
interventional phase IIb study. Forty patients with clinically and histologically confirmed
nummular eczema will be enrolled according to inclusion and exclusion criteria. Patients will
be included after written informed consent is obtained. Prior to randomization, average
application rate of class II topical steroids per day will be measured for 4 weeks.
Subsequently, patients will be randomized in a 1:1 ratio into one arm to receive Apremilast
30 mg BID (following titration phase) for 16 weeks or a second arm receiving identically
matching placebo for 16 weeks. From beginning of week 17, all patients will start an
open-label treatment with Apremilast 30 mg BID until week 32. Concomitant use of topical
steroids (class II) is allowed during the study. During the treatment period both placebo and
Apremilast will be applied p.o. from week 0 until week 32.