In this phase 1 open label study for patients with type I punctate palmoplantar keratoderma or pachyonychia congenital, 2 arms will be recruited to be treated twice daily, with 1% topical KM-001. Arm 1: up to 10 eligible patients will be treated for 12 weeks. Arm 2: up to 8 eligible patients will be treated for 16 weeks. Treatment safety and efficacy will be assessed in the clinic visits (for arm 1 up to day 91, for arm 2 up to day 126). In between safety will also be assessed by phone visits. At the in-clinic visits, treatment efficacy (lesion clearance - IGA, CGI-S, PGI-C, PGI-S and VAS pain) will also be assessed. PK blood samples will be collected for arm 1: on Days 0, 7, 84 (EoT visit). One week after the end of treatment (EoT) visit, patients will return to the clinic for final safety, efficacy and PK evaluations. For arm 2, PK blood samples will be collected on days 0, 7, 84, 112 (EoT visit). Two weeks after the end of treatment (EoT) visit, patients will return to the clinic for final safety, efficacy and PK evaluations.
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Safety endpoint will be assessed through collection and analysis of adverse events
Timeframe: up to 91 days for arm 1 and 126 days for arm 2
Safety endpoint-will be assessed through collection and analysis of blood laboratory tests.
Timeframe: up to 91 days for arm 1 and 126 days for arm 2
Safety endpoint-will be assessed through collection and analysis of urine laboratory tes
Timeframe: up to 91 days for arm 1 and 126 days for arm 2
Safety endpoint-Vital signs- Heart rate
Timeframe: up to 91 days for arm 1 and 126 days for arm 2
Safety endpoint-Vital signs- Blood Pressure
Timeframe: up to 91 days for arm 1 and 126 days for arm 2
Safety endpoint-ECG
Timeframe: up to 91 days for arm 1 and 126 days for arm 2
Safety endpoint- Lesion Assessment
Timeframe: up to 91 days for arm 1 and 126 days for arm 2