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

Sponsor
Technical University of Munich
Study ID
NCT03160248
Phase
PHASE2
Status
Completed

Conditions

  • Dermatitis Eczema
  • Eczema
  • Nummular Dermatitis
  • Nummular Eczema

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
May 19, 2017
Start date
Jul 5, 2017
Status verified
Oct 2020
Primary completion
Sep 15, 2021
Completion
Sep 15, 2021

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast
    Patients randomized to this arm will start Apremilast with a titration phase of 5 days, followed by 30 mg Apremilast tablets twice daily (BID) by mouth (PO) for a total of 32 weeks (including titration phase).
  • Experimental: Placebo + Apremilast
    Patients randomized to this arm will receive identically matching placebo (including the titration phase) by mouth for first 16 weeks. Placebo participants will be switched to receive Apremilast 30 mg BID from beginning of Week 17 for another 16 weeks. In this arm Apremilast will be started without titration.

Primary Outcome Measure

PGA [ Time Frame: week 16 ]

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