allergic contact dermatitis MedDRA version: 18.1 Level: LLT Classification code 10056265 Term: Allergic contact dermatitis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Cosentyx
Product Name: secukinumab
Pharmaceutical Form:
INN or Proposed INN: secukinumab
CAS Number: 1229022-83-6
Other descriptive name: SECUKINUMAB
Concentration unit: mg milligram(s)
C
Sponsors
Herlev and Gentofte Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study1 Main criteria for inclusion Patients must be > 18 Have a known nickel allergy with at least a +2 reaction when challenged with nickel Patients must have given their informed consent to the protocol and the clinical procedures Be able to speak and understand Danish. Study2 Main criteria for inclusion Patients must be > 18 Have at least two known contact allergies Moderate to severe dermatitis at inclusion Failure to local anti-inflammatory treatment and to at least one systemic anti-inflammatory treatment Patients must have given their informed consent to the protocol and the clinical procedures Be able to speak and understand Danish Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Study 1 Main criteria for exclusion Patients who have received any local anti-inflammatory treatment 2 weeks prior to day 0 Patients who have received any systemic anti-inflammatory treatment 4 weeks prior to day 0 Patients who have received any other study medication 4 weeks prior to day 0 Dermatitis at the upper inner arm Patients with clinically significant disorders Patients with active TB/serious infections Women of child-bearing potential must use effective contraception which includes IUD, oral, injected or implanted hormonal device, hormone patch, vaginal hormonal ring, sterilization, occlusive cap or condom with spermicidal cream. Post-menopausal women (> 12 months of amenorrhea) are allowed not to use contraception. Pregnancy Nursing Patients who have received any weakened vaccines 6 weeks prior to day 0 or who are planning to receive a weakened vaccine during the study Latex allergy Study2 Main criteria for exclusion Patients who have received any local anti-inflammatory treatment 2 weeks prior to day 0 Patients who have received any systemic anti-inflammatory treatment 4 weeks prior to day 0 Patients who have received any other study medication 4 weeks prior to day 0 Patients with clinically significant disorders Patients with active TB/serious infections Women of child-bearing potential must use effective contraception which includes IUD, oral, injected or implanted hormonal device, hormone patch, vaginal hormonal ring, sterilization, occlusive cap or condom with spermicidal cream. Post-menopausal women (> 12 months of amenorrhea) are allowed not to use contraception. Pregnancy Nursing Patients who have received any weakened vaccines 6 weeks prior to day 0 or who are planning to receive a weakened vaccine during the study Latex allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study will evaluate secukinumab treatment in patients with known allergic contact dermatitis. The study which is an interventional type will consist of two parts both performed at Department of Dermato-allergology, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark. Study 1 Study 1 will include 10 patients with known allergy to nickel, but with no to low grade of eczema at inclusion. 1.Reduction in clinical patch test score for dermatitis after secukinumab treatment compared to patch test score before secukinumab treatment in patients challenged with nickel. ;Secondary Objective: Secondary objective 2.Reduction in level of inflammation, CD4+, CD8+ T-cells, IFN-? and IL-17 positive cells in punch biopsy after treatment with secukinumab compared to level of inflammation, CD4+, CD8+ T-cells, IFN-? and IL-17 positive cells in punch biopsy before treatment with secukinumab in patients challenged with nickel. 3.Reduction in skinfold thickness in the nickel patch test area after treatment with secukinumab compared to skinfold thickness in the patch test area before treatment with secukinumab in patients challenged with nickel. ;Primary end point(s): Please see section E2;Timepoint(s) of evaluation of this end point: 1/7-17 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Please see section E2;Timepoint(s) of evaluation of this end point: 1/7-17 | — |
Countries
Denmark
Contacts
Public ContactDept of dermato-allergology
Herlev and Gentofte Hospital
Outcome results
None listed