Contact dermatitis
Conditions
Interventions
120 mg BAY 1834845, 100 mg BAY 1830839, placebo, or 20 mg prednisolone orally
administered twice daily for 7 days.
Sponsors
Bayer AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. 2. Overtly healthy as determined by medical evaluation including medical and surgical history, physical examination, laboratory tests, ECG and vital signs. 3. Participant has Fitzpatrick skin phototypes I (very fair), II (fair), or III (darker white skin). 4. Body weight must be above 50 kg and body mass index (BMI) above or equal 18.5 and lower or equal 28 kg/m2 at the screening visit. 5. Male.
Exclusion criteria
Exclusion criteria: 1. Medical disorder, condition or history of such that would impair the participant's ability to take part in or complete this study in the opinion of the investigator 2. A history of relevant diseases of vital organs, of the central nervous system including neuropsychiatric illness or other organs, previous syncope or autoimmune disease such as multiple sclerosis, inflammatory bowel disease, rheumatoid arthritis or other immune-inflammatory diseases. 3. Unintended weight loss or gain of at least 5 kg in 4 weeks at screening. 4. Any serious concomitant illness that anticipates the need of systemic medication interfering with the study medication. 5. A history of trauma with likely damage to the spleen, surgery to spleen or congenital abnormalities of the spleen. 6. Hemorrhagic diathesis (easy bruising, epistaxis, gastro-intestinal bleeding). 7. History of known pulmonary embolism or known anti-phospholipid syndrome. 8. Previous participation in an i.v./systemic LPS challenge trial or prior exposure to endotoxin within one year before start of treatment. 9. Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal (cholecystectomy permitted). 10. Any infection requiring hospitalization, systemic antimicrobial therapy within 60 days, or as otherwise judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months prior to treatment period. 11. Any active or ongoing chronic infectious disease including periodontitis with the exception of common viral or fungal skin infections such as plantar warts or athlete's foot. 12. Febrile illness within 30 days before the start of the first study intervention. 13. Medical history of sepsis, tuberculosis, increased frequency of infections, immunodeficiency diseases, with recent febrile diseases and anamnestic and/or laboratory signs of an impaired immune status or latent infections (hepatitis B, hepatitis C, and human immunodeficiency virus [HIV]). 14. History of COVID-19 within 6 months prior to treatment period or in case of clinically relevant sequela of former COVID-19 (such as fatigue or exercise dyspnea) 15. Contact with SARS-CoV-2- positive or COVID-19 patient within the last 2 weeks prior to SARS-CoV-2 viral PCR test (at visit 2). 16. History of major surgery within 8 weeks prior to treatment period or scheduled (elective) surgery, planned hospitalization and surgical dental treatment within study and 4 weeks after final follow-up. 17. History of or acute atopic dermatitis with active eczematous lesions, bronchial asthma or allergic rhino-conjunctivitis symptomatic during screening period. 18. History of other concomitant skin conditions (chronic inflammatory dermatoses) that would interfere with the evaluation of the effect of the study medication on contact dermatitis. 19. History of hypersensitivity to any of the components of the study interventions. 20. History of malignant tumors (except treated basal cell carcinoma). 21. Any clinical contraindications to treatment with steroids, such as uncontrolled hypertension, chronic liver disease (Child*Pugh scores B or C), latent diabetes mellitus, history of gastrointestinal bleeding. 22. Use of topical and systemic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Average change of perfusion/basal flow and erythema 2. Average change in systemic inflammation markers (TNF-*, IL-6) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change of perfusion/basal flow and erythema at individual timepoints 2. Average change of Clinician Erythema Assessment (CEA) score 3. Measurement of molecular changes (cytokines and immune cells) 4. Changes in immune cells, immune phase reactants such as CRP and other inflammation markers caused by the systemic challenge 5. Changes in temperature, pulse rate, systolic and diastolic blood pressure | — |
Countries
Netherlands
Outcome results
None listed