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

NCT03160248 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-10-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Kilian Eyerich · Technical University Munich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2021-09-15
Completion
2021-09-15

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03160248 on ClinicalTrials.gov