This Phase 1b, open-label, single-center, prospective trial will be assessing the safety, tolerability, and efficacy of topical KM-001 1% in patients with PPPK1 or PC diseases. In this study 2 cohorts will be recruited: 1. Cohort 1: up to 11 eligible patients, will be enrolled to be treated twice daily, for 12 weeks, with 1% topical KM-001, on the plantar surfaces (2 feet). 2. Cohort 2: up to 8 eligible patients, will be enrolled to be treated twice daily, for 16 weeks, with 1% topical KM-001, on the plantar surfaces (2 feet). Safety (AEs, blood work \[at specific visits\], vital signs), tolerability, and efficacy parameters (overall lesion improvement) will be assessed during in-clinic visits (Cohort 1: during Screening, Enrolment, and on Days 7, 28, 42, 63, 84 \[end of treatment, EoT\], 112 \[End of Study, EoS\] post first investigational medicinal product (IMP) administration; Cohort 2: during Screening, Enrolment, and on Days 7, 28, 42, 63, 84, 112 \[EoT\], 140 \[EoS\] post first investigational medicinal product (IMP) administration). PK samples will be collected to assess plasma levels of KM-001 on * Screening (Day -14 to -0): any time during the visit. (or on Day 1 up to 30 minutes pre-dose if missed during Screening) * Day 7 and at EoT (Cohort 1: Day 84; Cohort 2: Day 112) up to 30 minutes pre-dose, and at 1 h, 2 h, 3 h, 6 h (+15 min) post-dose * Days 28, 42 for both Cohorts, and Day 84 for Cohort 2: 1 sample after the first dose, before the second dose, as late as possible in the visit. * End of Study (EoS, Day 112 (Cohort 1) or Day 140 (cohort 2)), or at Early Termination (ET): at any time during the visit. The patient will complete a patient-reported diary, consisting of treatment compliance and self-assessments for efficacy. Follow up- 2 weeks after EoT by phone call, and 4 weeks after EoT in clinic visit.
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Safety endpoint will be assessed through collection and analysis of adverse events.
Timeframe: Up to 112 days
Safety endpoint-will be assessed by the % of change from normal range in the collection of Hematology- laboratory blood test profile.
Timeframe: Up to 112 days
Safety endpoint-will be assessed by the % of change from normal range in the collection of MCH result in laboratory blood test.
Timeframe: Up to 112 days
Safety endpoint-will be assessed by the % of change from normal range in the collection of MCV result in laboratory blood test.
Timeframe: Up to 112 days
Safety endpoint-will be assessed by the % of change from normal range in the collection of haematocrit result in laboratory blood test.
Timeframe: Up to 112 days
Safety endpoint-will be assessed by the % of change from normal range in the collection of hemoglobin result in laboratory blood test.
Timeframe: Up to 112 days
Safety endpoint-will be assessed by the % of change from normal range in the collection of RBC result in laboratory blood test.
Timeframe: Up to 112 days
Safety endpoint-will be assessed by the % of change from normal range in the collection of Sodium, potassium and chloride results in chemistry laboratory blood test.
Timeframe: Up to 112 days
Safety endpoint-will be assessed by the % of change from normal range in the collection of: Glucose fasting , BUN/Ur, creatinine, bilirubin total and direct, calcium, uric acid, and bilirubin result, in chemistry laboratory blood test.
Timeframe: Up to 112 days
Safety endpoint-will be assessed by the % of change from normal range in the collection of Alkaline phosphatase, AST, ALT and GGT result in chemistry- laboratory blood test.
Timeframe: Up to 112 days
Safety endpoint-will be assessed by the % of change from normal range in the collection of Albumin and total protein result in chemistry- laboratory blood test.
Timeframe: Up to 112 days
Safety endpoint-will be assessed by the % of change from normal range in the collection of Serology -in laboratory blood test profile.
Timeframe: Up to 112 days
Safety endpoint-will be assessed by the % of change from normal range in the collection of urine laboratory profile.
Timeframe: Up to 112 days
Safety endpoint-will be assessed by the % of change from normal range in the collection of Specific gravity , pH, blood and nitrites result in urine laboratory profile.
Timeframe: Up to 112 days
Safety endpoint-Mean change in body temperature measurement from baseline.
Timeframe: Up to 112 days
Safety endpoint-Mean change in pulse measurement from baseline.
Timeframe: Up to 112 days
Safety endpoint- Mean change in blood pressure measurement from baseline.
Timeframe: Up to 112 days
Safety endpoint-ECG
Timeframe: Up to 112 days