Erythema Trials in Disease

Study on Treating Keratolytic Winter Erythema in Adults Using Nitroxoline

This clinical trial is investigating the effectiveness of Nitroxoline in treating Keratolytic Winter Erythema (KWE), a rare genetic skin disorder that causes red, scaly patches on the skin, particularly during winter months. The study follows a crossover design, meaning participants will receive both the active medication and a placebo at different times during the 26-week trial period.

Main inclusion criteria:

• Confirmed diagnosis of Keratolytic Winter Erythema through genetic testing (either personal or close family member)
• Age 18 years or older
• Body weight of at least 50 kilograms (approximately 110 pounds)
• Women of childbearing potential must use effective contraception throughout the study
• Ability to provide signed informed consent and follow study requirements

Main exclusion criteria:

• Patients without Keratolytic Winter Erythema
• Patients outside the specified age range
• Vulnerable populations requiring special protection or care

Trial focus and goals:

The primary goal of this study is to determine whether Nitroxoline can effectively reduce the total area of skin affected by KWE over a 22-week treatment period. Participants will be adults from three Norwegian families diagnosed with this condition. The trial will monitor changes in the size and severity of skin patches, assess any side effects, and evaluate the impact on quality of life, including factors such as pain, itchiness, and overall well-being.

The study involves several phases. After providing informed consent and undergoing baseline assessments, participants are randomly assigned to receive either Nitroxoline (250 mg capsules taken orally) or a placebo for 22 weeks. Throughout this period, regular monitoring visits include physical examinations and laboratory tests. After the initial phase, participants switch to the opposite treatment group for another 22 weeks. Final assessments at the end of the study evaluate the overall effectiveness of the treatment.

Investigational drug:

Nitroxoline is an antibiotic medication being tested for its ability to treat KWE. At the molecular level, it works by inhibiting bacterial enzymes, which may help reduce inflammation and skin symptoms. The trial aims to establish whether this oral medication can provide relief from the uncomfortable symptoms of KWE, including the characteristic redness, scaling, and peeling of the skin.