NCT03160248

An Investigator-initiated Study of Apremilast to Demonstrate Efficacy Nummular Eczema

An Investigator-initiated, Randomized, Double-blind, Placebo Controlled Study of Apremilast to Demonstrate Efficacy in Subjects With Nummular Eczema

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nummular Eczema
• Eczema
• Dermatitis Eczema
• Nummular Dermatitis

Interventions

Type	Name	Description
DRUG	Apremilast	This study aims on investigating the efficacy of Apremilast in nummular eczema patients.
DRUG	Placebo Oral Tablet	This study aims on investigating the efficacy of Apremilast in nummular eczema patients - placebo controlled

Timeline

• Start date: 2017-07-05
• Primary completion: 2021-09-15
• Completion: 2021-09-15
• First posted: 2017-05-19
• Last updated: 2021-10-08

Locations

1 site across 1 country: Germany