BridgeMD
Treatment of Keratolytic Winter Erythema in adults with systemic nitroxoline
EU CTIS ID: 2022-501726-38-00
What this study is testing
Determine the effectiveness of per os Nitroxoline treatment on total skin area affected by KWE over a 22 week time period
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility criteria
- 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 γ-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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.