KM-001 Cream for Treatment of Pruritus in Adult Patients With Lichen Simplex Chronicus (LSC)

Exclusion Criteria

• •1. Known hypersensitivity or any suspected cross-allergy to the active pharmaceutical ingredient (API) and/or excipients.
• •2. Chronic pruritus resulting from another active condition other than LSC such as, but not limited to, psoriasis, atopic dermatitis, lichen planus contact dermatitis, folliculitis, habitual picking, bullous autoimmune disease, neuropathy.
• •3. Genital, anal or scalp LSC.
• •4. History of or current confounding skin condition (psoriasis, cutaneous T-cell lymphoma \[mycosis fungoides or Sezary syndrome\], chronic actinic dermatitis with \[present or previous\] skin cancer on the site of LSC, bullous disorders, dermatitis herpetiformis).
• •5. Cutaneous infection within 1 week before the screening visit or any infection requiring treatment with oral, parenteral antibiotics, antivirals, antiparasitics or antifungals or any topical within 1 week before the screening visit. Patients may be rescreened once the infection has resolved.
• •6. Positive hepatitis B surface antigen \[HBsAg\], hepatitis B core antibody \[HBcAb\], hepatitis C antibody, or human immunodeficiency virus antibody serology results at the screening visit.
• •7. Patients with active atopic dermatitis.
• •8. Neuropathic and psychogenic pruritus, such as, but not limited to, notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis.
• •9. Patients with the following medical conditions:
• •1. High blood pressure (BP), defined as resting systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg (according to 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice \[18\]).
• •2. Patients with poorly controlled and/or complicated (retinopathy/nephropathy/neuropathy) diabetes glycosylated hemoglobin (HbA1c) of \>7%, fasting serum glucose \>130 mg/dl.
• •3. Patients with history of angina pectoris and/or myocardial infarction.
• •4. Systemic autoimmune conditions (including, but NOT limited to: systemic lupus erythematosus, rheumatoid arthritis etc.).
• •5. Small fiber neuropathy.
• •6. Any other condition that could, in the investigator's opinion, affect patient safety, his ability to participate in the study or ability of the investigator to assess the skin.
• •10. Having received any of the prohiboted treatments in Table 1 within the specified timeframe before the baseline visit.
• •11. Pregnant women (positive serum pregnancy test result at the screening and baseline visits), breastfeeding women, or women planning a pregnancy during the clinical trial.
• •12. History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for:
• •1. Basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that had been treated and with no evidence of recurrence in the last 52 weeks before the baseline visit, or;
• •2. Actinic keratoses that had been treated and with no evidence of recurrence in the last 8 weeks.
• •13. Any known or suspected state of immunodeficiency due to primary or secondary immunodeficiency syndromes, organ transplants (except corneal transplant), previous opportunistic infection, or any other state of immunodeficiency as judged by the investigator.
• •14. Any clinically relevant disorder or abnormal finding which could affect the safety of the patient throughout the study and/or impede the patient's ability to complete the study, as assessed by the investigator.
• •15. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or bilirubin exceeding the upper limit of normal (ULN), or any other laboratory abnormalities considered clinically relevant by the investigator, at the screening/baseline visit.
• •16. Any condition that may put the patient at significant risk according to the investigator's judgment.
• •17. Any disorder which may interfere with study assessments (e.g., poor venous access or needle-phobia).
• •18. Major surgical procedure planned or expected during the clinical trial.
• •19. Patient is unwilling to refrain from using prohibited medications during the clinical trial.
• •20. Currently participating or participated in any other study of a drug or device, within the past 2 months before the screening visit, or is in an exclusion period (if verifiable) from a previous study.
• •21. Close affiliation with the investigator (e.g., a close relative) or persons working at bioskin GmbH or the study sites or patient is an employee of sponsor.
• •22. Patient is institutionalized because of legal or regulatory order.
• •23. Patients who have been administered any vaccine for COVID-19 within 30 days prior to first treatment.
• •24. Tattoos and scars in the areas to be treated.