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

> **NCT05956314** · PHASE1 · COMPLETED · sponsor: **Kamari Pharma Ltd** · enrollment: 18 (actual)

## Conditions studied

- 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.

## Key facts

- **NCT ID:** NCT05956314
- **Lead sponsor:** Kamari Pharma Ltd
- **Sponsor class:** NETWORK
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2023-03-06
- **Primary completion:** 2024-11-07
- **Final completion:** 2024-11-07
- **Target enrollment:** 18 (ACTUAL)
- **Last updated:** 2025-01-15


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05956314

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05956314, "Assessment of KM-001 - Safety, Tolerability, and Efficacy in Patients With PPPK1 or PC". Retrieved via AI Analytics 2026-07-08 from https://api.ai-analytics.org/clinical/NCT05956314. Licensed CC0.

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