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 · clinicaltrials.gov ↗

PHASE1

Phase

COMPLETED

Status

14

Enrollment

NETWORK

Sponsor class

Conditions

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

Sponsor

Kamari Pharma Ltd