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

Summary

This is a phase 1, multi-center, randomized, vehicle-controlled, double-blinded, parallel-group study.

Approximately 6 sites will conduct the study at Germany. Approximately 61 patients (male and female) planned to be screened. 51 patient planned to be randomized.

Patients will be randomized to 1 of 3 treatment arms (KM-001 0.3%, KM-001 1%, or vehicle cream) iina a ration of 1:1:1

Patient's duration of participation will be up to 7 weeks,

* a screening period with 1 visit (Visit 1) within up to 14 days (Days -14 to -1),
* a 4-week treatment period with 3 visits (Visit 2 on Day 0, Visit 3 on Day 7, Visit 4 at Day 28 and 2 phone calls on Days 14 and 21, and
* a 1-week follow-up period with 1 visit (Visit 5 on Day 35), as well as unscheduled visits as needed

Since KM-001 is tested in humans for the first time, the safety of KM-001 will be evaluated in a subgroup of 6 patients (sentinel group) at selected sites prior to screening of the remaining sites.

Efficacy assessments will include subjective assessments of itch and investigator assessment of the treatment effect on LSC target lesion using scoring systems.

Safety parameter (including physical examination, vital signs, ECG, standard laboratory test, and PK analysis) will be monitored from the signing of the informed consent form (ICF) until the last follow-up visit. Recording of AEs and serious AEs (SAEs) will be done throughout the study with special attention to local AEs in the treatment area (LSC target lesion, dermal safety).

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

Sponsors & Collaborators

• Bioskin GmbH

  collaborator INDUSTRY

• Kamari Pharma Ltd

  lead NETWORK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-24

Primary Completion

2023-04-04

Completion

2023-04-04

Countries

• Germany

Study Locations