Nummular eczema (NE) is an idiopathic chronic inflammatory skin disease that occurs throughout all life periods. Diagnosis is made primarily clinically in correlation with histological findings. Treatment of NE is difficult. Standard treatment consists of the use of emollients, topical as well as systemic corticosteroids and phototherapy. Nevertheless, remission is hard to achieve and relapse occurs often. Patients usually suffer from severe pruritus and reduced quality of life. Therefore, new therapeutic strategies are urgently needed. Dupilumab (Dupixent®), a monoclonal antibody inhibiting the IL-4 and IL-13 pathway by targeting the IL-4-receptor, has been approved for the treatment of moderate-to-severe atopic dermatitis (AD). Since there is an overlap between AD and NE with both being caused by impaired epidermal barrier, broad immune-mediated inflammation and microbial skin colonization, using Dupilumab in NE seems to be promising.
This study aims on investigating the efficacy of Dupilumab in NE patients. The primary endpoint is the percent change in Eczema Area and Severity Index (EASI) score from baseline to week 16. Secondary endpoints include the number of patients achieving an improvement (decrease) in Physician Global Assessment (PGA) 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, the EASI 50 score at week 16, the change from baseline in transepidermal waterloss (TEWL) at week 16, significant histological improvement at week 16, change from baseline in the reduction of the use of topical steroids at week 16, change form baseline in the Dermatology Life Quality Index (DLQI) at week 16, change from baseline in Pruritus Visual Analog Scale (VAS), change from baseline in the global satisfaction subscale of the treatment satisfaction questionnaire for medication (TSQM) score at week 16 and the safety of Dupilumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Klinikum re. Isar Dermatology
München, Bavaria, Germany
EASI
The primary endpoint is the percent change in Eczema Area and Severity Index (EASI) score.
Time frame: From baseline to week 16.
PGA
Number of Patients Achieving an Improvement (Decrease) in Physician Global Assessment (PGA) by two or more points
Time frame: at week 16 as compared to week 0
PGA
Number of Patients achieving an absolute PGA of 0 or 1
Time frame: at Week 16.
EASI
The proportion of subjects who achieve at least a 50% reduction in the EASI score
Time frame: From baseline to week 16
TEWL
Restoration of epidermal barrier function assessed by TEWL (Transepidermal Waterloss) will be measured using AquaFlux BIOX.
Time frame: From baseline to week 16
histological improvement
Assessed by reduction of epidermal thickness \> 30% or reduction of inflammatory infiltrate \> 50 %
Time frame: From baseline to week 16
Reduction of the Use of Topical Steroids
Prior to randomization and during the treatment, average application rate of class II topical steroids (standard medication "prednicarbate") per day will be calculated
Time frame: From baseline to week 16
DLQI
Change from Baseline in the Dermatology Life Quality Index (DLQI)
Time frame: Total Score at Week 16
VAS
Pruritus Visual Analog Scale
Time frame: Total Score at Week 16
TSQM
Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication
Time frame: Total Score at Week 16
Adverse Events
Type, incidence, severity, and relationship of the AEs to study medication
Time frame: From baseline to week 16
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