KM-001 Cream for Treatment of Pruritus in Adult Patients With Lichen Simplex Chronicus (LSC)

PHASE1CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

May 24, 2022

Primary Completion Date

April 4, 2023

Study Completion Date

April 4, 2023

Conditions
Lichen Simplex Chronicus
Interventions
DRUG

IMP Application KM-001

KM-001 will be supplied in glass jars (30 ml) and will be provided to patients with spatulas and polyethylene gloves on all the clinical visits. the patient will use IMP twice a day for 28 days.

DIAGNOSTIC_TEST

Chemistry

patients will provide a blood sample for a chemistry blood test on days -14 (screening visit), Day 7(visit 3), day 28 (end of treatment) or at ET visit.

DIAGNOSTIC_TEST

Hematology

patients will provide a blood sample for a hematology blood test on days -14 (screening visit), Day 7(visit 3), day 28 (end of treatment) or at ET visit.

DIAGNOSTIC_TEST

Urinalysis

Patients will provide a blood sample for a urine test on days -14 (screening visit), Day 7(visit 3), day 28 (end of treatment) or at ET visit.

DIAGNOSTIC_TEST

Serelogy

Patients will provide a blood sample for serelogy test at day -14 (screening visit)

DIAGNOSTIC_TEST

12-Lead ECG

patients will undergo an ECG examination on days -14 (screening visit), and day 28 (end of treatment visit).

DIAGNOSTIC_TEST

Pregnancy test

Women of child-bearing potential only will provide at all the on-site visits b-hCG concentration will be tested

DIAGNOSTIC_TEST

Blood PK sampling

PK test will be performed on day 1, 7, 28, 35 and on ET visit

PROCEDURE

Physical Examination

patients will undergo a physical examination on all the clinical visits

PROCEDURE

Vital signa

patient's vital signs will be measured on all the clinical visits

DIAGNOSTIC_TEST

Investigator's Global Assessment

patient's disease evaluations will be evaluated on all the clinical visits

DIAGNOSTIC_TEST

Itch Assessment via PP-NRSj

patient's disease evaluations will be evaluated on all the clinical visits

OTHER

E-diary data

The patient will record IMP adminidsration and AE events in a diary every day throughout the all study period

Trial Locations (2)

10783

Rothhaar Studien GmbH, Berlin

48455

Fachklinik Bad Bentheim - Dermatologische Studienambulanz, Bensheim

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bioskin GmbH

INDUSTRY

lead

Kamari Pharma Ltd

NETWORK

NCT05454462 - KM-001 Cream for Treatment of Pruritus in Adult Patients With Lichen Simplex Chronicus (LSC) | Biotech Hunter | Biotech Hunter