Treatment of KeratolytTreatment of Keratolytic Winter Erythema with systemic nitroxoline, a phase 2a randomized placebo controlled crossover study of male and female adults from three Norwegian familiesic Winter Erythema with systemic Nitroxoline, a phase 2a randomized placebo controlled cross-over study of male and female adults from three Norwegian families. - 1.0

Oslo University Hospital Hf0 个研究点目标入组 12 人开始时间: 2022年8月26日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•Participant have the diagnosis of KWE (typical clinical features confirmed by genetic testing of the patient or a first degree relative), Participant is = 18 years of age, Body weight is = 50 kg, Fertile women must use effective contraception during the entire study period as defined in Appendix 4, The participant must be capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

•Known allergy or intolerance to nitroxoline, The participant must use other medication(s) incompatible with the simultaneous use of nitroxoline (including warfarin and other vitamin K-antagonists), Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures, Hypersensitivity to any ingredients in the placebo capsule, Known allergy or intolerance to any other ingredients in Nitroxolin Forte capsules (see SPC), in particular soy protein or Ponceau 4R (E124), Chronic renal failure stage 3b-5 (estimated glomerular filtration rate <45 mL/min/1,73m2), Abnormal liver test values of ALAT, ASAT or ?-GT >3 × above upper limit of normal (ULN), total bilirubin >2 × ULN or spontaneous INR >1.5, Known unstable or progressive liver disease (e.g., liver cirrhosis, fatty liver, active hepatitis), The participant is pregnant, The participant is breastfeeding, The participant has a thrombocyte level below 100 x 109 per liter

发起方

Oslo University Hospital Hf