Assessment of KM-001 - Safety, Tolerability, and Efficacy in Patients With PPPK1 or PC

Conditions

• Punctate Palmoplantar Keratoderma Type 1
• Pachyonychia Congenita

Interventions

• DRUG: KM-001 cream 1% 12 weeks treatment.
• DIAGNOSTIC_TEST: Physical Examination
• DIAGNOSTIC_TEST: Vital Signs
• DIAGNOSTIC_TEST: Serum chemistry
• DIAGNOSTIC_TEST: Hematology
• DIAGNOSTIC_TEST: Serology
• DIAGNOSTIC_TEST: Urinalysis
• DIAGNOSTIC_TEST: ECG test
• DIAGNOSTIC_TEST: Pharmacokinetics Assessments
• DIAGNOSTIC_TEST: Clinical global impression of severity (CGI-S)
• DIAGNOSTIC_TEST: Visual Analogue Scale (VAS) pain scale
• DIAGNOSTIC_TEST: Peak pruritus-numerical rating scale (PP-NRS)
• DIAGNOSTIC_TEST: Patient global impression of change (PGI-C) scoring
• DIAGNOSTIC_TEST: Patient global impression of severity (PGI-S) scoring
• DIAGNOSTIC_TEST: Lesion photography
• DRUG: KM-001 cream 1% 16 weeks treatment.

Sponsor

Kamari Pharma Ltd