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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
This study aims on investigating the efficacy of Apremilast in nummular eczema patients.
This study aims on investigating the efficacy of Apremilast in nummular eczema patients - placebo controlled
Technical University Munich - Department of Dermatology
Munich, Bavaria, Germany
PGA
Number of Patients Achieving an Improvement (Decrease) in PGA (Physician Global Assessment) by two or more points at week 16 as compared to week 0 or achieving an absolute PGA of 0 or 1 at Week 16
Time frame: week 16
EASI
EASI 50 score at week 16 and 32 (Eczema Area and Severity Index)
Time frame: week 16 and 32
Transepidermal Waterloss (TEWL)
Change From Baseline in Transepidermal Waterloss (TEWL) at week 16 and 32
Time frame: week 16 and 32
Histology
Significant histological improvement at week 16 - Assessed by reduction of epidermal thickness \> 30% or reduction of inflammatory infiltrate \> 50 % compared to histological findings on baseline.
Time frame: week 16
Use of topical steroids
Change From Baseline in the Reduction of the Use of Topical Steroids at week 16 and 32 \- Prior to randomization and during the treatment, average application rate of class II topical steroids per day will be calculated. Participants will receive "prednicarbate" from the study centre. On each visit the tube will be weighed to measure usage.
Time frame: week 16 and 32
PGA score Arm 2
Change in PGA score compared to baseline and week 16 for patients in Arm 2 at week 32 \- Comparison of the first and the second 16 weeks of the trial in terms of the change in PGA score from baseline for patients in Arm 2
Time frame: week 32
DLQI
Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 and 32
Time frame: week 16 and 32
Pruritus Visual Analog Scale (VAS)
Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16 and 32
Time frame: week 16 and 32
TSQM
Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) Score at Week 16 and 32
Time frame: week 16 and 32
Safety: Safety of Apremilast will be Assessed by Evaluating Adverse Events (AEs) - Type, frequency, severity, and relationship of the AEs to apremilast
Safety of Apremilast will be Assessed by Evaluating Adverse Events (AEs) - Type, frequency, severity, and relationship of the AEs to apremilast
Time frame: week 36
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