The purpose of this study is to explore the efficacy and safety of anti-Interleukin-(IL)17 therapy (secukinumab, administered weekly for 4 weeks followed by four-weekly administration until week 16) for the treatment of pyoderma gangrenosum.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Technical University of Munich
Munich, Germany
Change of the Physician's global assessment
The primary response parameter change of the physician global assessment (PGA) 5-point scale at week 16 as compared to week 0.
Time frame: Week 16
Change in surface area of lesions of pyoderma gangrenosum (two-dimensional surface in mm²)
Time frame: Week 2,3,8,16,28,40
Assessment of patient's quality of life
Patient's quality of life is assessed by the Dermatology Life Quality Index (DLQI) questionnaire.
Time frame: Week 2, 4, 8, 16, 28, 40
Measurement of serum C reactive protein (mg/dl)
Time frame: Week 2, 4, 8, 16, 28, 40
Measurement of leukocyte counts (x10.e3/µl)
Time frame: Week 2, 4, 8, 16, 28, 40
Measurement of blood sedimentation rate (mm/h)
Time frame: Week 2, 4, 8, 16, 28, 40
Immunohistochemical analysis of IL-17+ immune cells
The number of IL-17+ immune cells is counted in two high-power-fields (400x) and mean in calculated.
Time frame: Week 16
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