# Study Designed to Evaluate Safety and Efficacy of 1% Topical Formulation of KM-001 on Type 1 Punctate Palmoplantar Keratoderma or Pachyonychia Congenita Diseases

> **NCT05435638** · PHASE1 · COMPLETED · sponsor: **Kamari Pharma Ltd** · enrollment: 14 (actual)

## Conditions studied

- Punctate Palmoplantar Keratoderma Type 1
- Pachyonychia Congenita

## Interventions

- **DIAGNOSTIC_TEST:** Serum chemistry
- **DIAGNOSTIC_TEST:** Hematology
- **DIAGNOSTIC_TEST:** Urinalysis
- **DIAGNOSTIC_TEST:** Physical Examination
- **DIAGNOSTIC_TEST:** Vital Signs
- **DIAGNOSTIC_TEST:** ECG Test
- **DIAGNOSTIC_TEST:** PK
- **DIAGNOSTIC_TEST:** IGA scoring
- **DRUG:** KM-001 1% cream 12 weeks treatment
- **DIAGNOSTIC_TEST:** Clinician global impression of severity (CGI-S)
- **DIAGNOSTIC_TEST:** Visual Analogue Scale (VAS)
- **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 1% cream 16 weeks treatment

## Key facts

- **NCT ID:** NCT05435638
- **Lead sponsor:** Kamari Pharma Ltd
- **Sponsor class:** NETWORK
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-07-17
- **Primary completion:** 2024-09-05
- **Final completion:** 2024-09-05
- **Target enrollment:** 14 (ACTUAL)
- **Last updated:** 2025-01-07


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05435638

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05435638, "Study Designed to Evaluate Safety and Efficacy of 1% Topical Formulation of KM-001 on Type 1 Punctate Palmoplantar Keratoderma or Pachyonychia Congenita Diseases". Retrieved via AI Analytics 2026-08-13 from https://api.ai-analytics.org/clinical/NCT05435638. Licensed CC0.

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