Completed PHASE1 INTERVENTIONAL 2-arm NCT05956314

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

Phase 1b, Open Label Study to Evaluate the Safety, Tolerability, and Efficacy of a 1% Topical Formulation of KM-001 for the Treatment of Type I Punctate Palmoplantar Keratoderma or Pachyonychia Congenita

Sponsor: Kamari Pharma Ltd

Conditions Pachyonychia Congenita Punctate Palmoplantar Keratoderma Type 1

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

Updated 7 times since 2023 Last updated: Jan 14, 2025 Started: Mar 6, 2023 Primary completion: Nov 7, 2024 Completion: Nov 7, 2024

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Pachyonychia Congenita and Punctate Palmoplantar Keratoderma Type 1 and is currently completed. Kamari Pharma Ltd leads this study, which shows 7 recorded versions since 2023 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

7 versions recorded

Feb 2025 — Present [monthly]

Completed PHASE1

Status: Active Not Recruiting → Completed
Nov 2024 — Feb 2025 [monthly]

Active Not Recruiting PHASE1

Status: Recruiting → Active Not Recruiting
Sep 2024 — Nov 2024 [monthly]

Recruiting PHASE1
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE1
Jun 2024 — Jul 2024 [monthly]

Recruiting PHASE1

▶ Show 2 earlier versions

May 2024 — Jun 2024 [monthly]

Recruiting PHASE1
Aug 2023 — May 2024 [monthly]

Recruiting PHASE1

First recorded

Mar 2023

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Kamari Pharma Ltd

Data source: Kamari Pharma Ltd

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• London, United Kingdom