KM-001 Cream for Treatment of Pruritus in Adult Patients With Lichen Simplex Chronicus (LSC) (NCT05454462) | Clinical Trial Compass
CompletedPhase 1
KM-001 Cream for Treatment of Pruritus in Adult Patients With Lichen Simplex Chronicus (LSC)
Germany55 participantsStarted 2022-05-24
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Read, understood, and signed an ICF before any investigational procedure(s) are performed.
✓. Male or female and aged ≥18 to 75 years at the time of screening.
✓. Chronic moderate to severe pruritus defined as:
✓. Itching that has been present for 6 weeks or more prior to the screening AND
✓. At the screening visit (Visit 1) and enrollment visit (Visit 2): peak pruritus-numerical rating scale (PP-NRS)24h is ≥7.
✓. Clinical diagnosis of LSC for at least 8 weeks prior to screening:
✓. LSC lesions defined as dry, scaly, thickened plaques of skin (lichenification) caused by repeated rubbing or scratching, on upper limbs, trunk, and/or lower limbs.
✓. To have no more than 3 lesions, total size not exceeding 5% of BSA from which one (target lesion) will be selected for treatment (minimum area of lesion selected for treatment: 0.5% BSA).
Exclusion criteria
✕
What they're measuring
1
Safety endpoint - Will be assessed through collection and analysis of adverse events
. Known hypersensitivity or any suspected cross-allergy to the active pharmaceutical ingredient (API) and/or excipients.
✕. Chronic pruritus resulting from another active condition other than LSC such as, but not limited to, psoriasis, atopic dermatitis, lichen planus contact dermatitis, folliculitis, habitual picking, bullous autoimmune disease, neuropathy.
✕. Genital, anal or scalp LSC.
✕. History of or current confounding skin condition (psoriasis, cutaneous T-cell lymphoma \[mycosis fungoides or Sezary syndrome\], chronic actinic dermatitis with \[present or previous\] skin cancer on the site of LSC, bullous disorders, dermatitis herpetiformis).
✕. Cutaneous infection within 1 week before the screening visit or any infection requiring treatment with oral, parenteral antibiotics, antivirals, antiparasitics or antifungals or any topical within 1 week before the screening visit. Patients may be rescreened once the infection has resolved.
✕. Positive hepatitis B surface antigen \[HBsAg\], hepatitis B core antibody \[HBcAb\], hepatitis C antibody, or human immunodeficiency virus antibody serology results at the screening visit.
✕. Patients with active atopic dermatitis.
✕. Neuropathic and psychogenic pruritus, such as, but not limited to, notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis.