Assessment of KM-001 - Safety, Tolerability, and Efficacy in Patients With PPPK1 or PC
Phase 1
Completed
- Conditions
- Punctate Palmoplantar Keratoderma Type 1Pachyonychia Congenita
- Interventions
- Drug: KM-001 cream 1% 12 weeks treatment.Diagnostic Test: Physical ExaminationDiagnostic Test: Vital SignsDiagnostic Test: Serum chemistryDiagnostic Test: HematologyDiagnostic Test: SerologyDiagnostic Test: UrinalysisDiagnostic Test: ECG testDiagnostic Test: Pharmacokinetics AssessmentsDiagnostic Test: Clinical global impression of severity (CGI-S)Diagnostic Test: Visual Analogue Scale (VAS) pain scaleDiagnostic Test: Peak pruritus-numerical rating scale (PP-NRS)Diagnostic Test: Patient global impression of change (PGI-C) scoringDiagnostic Test: Patient global impression of severity (PGI-S) scoringDiagnostic Test: Lesion photographyDrug: KM-001 cream 1% 16 weeks treatment.
- First Posted Date
- 2023-07-21
- Last Posted Date
- 2025-01-15
- Lead Sponsor
- Kamari Pharma Ltd
- Target Recruit Count
- 18
- Registration Number
- NCT05956314
- Locations
- š¬š§
Royal London Hospital-Clinical Research Facility-11D (11th Floor) Whitechapel, London, E1 1FR,, London, Whitechapel Rd, United Kingdom
KM-001 Cream for Treatment of Pruritus in Adult Patients With Lichen Simplex Chronicus (LSC)
Phase 1
Completed
- Conditions
- Lichen Simplex Chronicus
- Interventions
- Drug: IMP Application KM-001Diagnostic Test: ChemistryDiagnostic Test: HematologyDiagnostic Test: UrinalysisDiagnostic Test: SerelogyDiagnostic Test: 12-Lead ECGDiagnostic Test: Pregnancy testDiagnostic Test: Blood PK samplingProcedure: Physical ExaminationProcedure: Vital signaDiagnostic Test: Investigator's Global AssessmentDiagnostic Test: Itch Assessment via PP-NRSjOther: E-diary data
- First Posted Date
- 2022-07-12
- Last Posted Date
- 2024-04-02
- Lead Sponsor
- Kamari Pharma Ltd
- Target Recruit Count
- 55
- Registration Number
- NCT05454462
- Locations
- š©šŖ
Fachklinik Bad Bentheim - Dermatologische Studienambulanz, Bensheim, Germany
š©šŖRothhaar Studien GmbH, Berlin, Germany
Study Designed to Evaluate Safety and Efficacy of 1% Topical Formulation of KM-001 on Type 1 Punctate Palmoplantar Keratoderma or Pachyonychia Congenita Diseases
Phase 1
Completed
- Conditions
- Punctate Palmoplantar Keratoderma Type 1Pachyonychia Congenita
- Interventions
- Diagnostic Test: Serum chemistryDiagnostic Test: HematologyDiagnostic Test: UrinalysisDiagnostic Test: Physical ExaminationDiagnostic Test: Vital SignsDiagnostic Test: ECG TestDiagnostic Test: PKDiagnostic Test: IGA scoringDrug: KM-001 1% cream 12 weeks treatmentDiagnostic Test: Clinician global impression of severity (CGI-S)Diagnostic Test: Visual Analogue Scale (VAS)Diagnostic Test: Patient global impression of change (PGI-C) scoringDiagnostic Test: Patient global impression of severity (PGI-S) scoringDiagnostic Test: Lesion photographyDrug: KM-001 1% cream 16 weeks treatment
- First Posted Date
- 2022-06-28
- Last Posted Date
- 2025-01-07
- Lead Sponsor
- Kamari Pharma Ltd
- Target Recruit Count
- 14
- Registration Number
- NCT05435638
- Locations
- š®š±
Soroka Medical Center, Beer-Sheva, Israel
š®š±Rabin Medical Center (Beilinson, Hasharon), Petah Tikva, Israel
š®š±Sourasky Medical Center - Ichilov Hospital, Tel Aviv, Israel
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