Subclinical lesions in UV-exposed areas of chronically UV-damaged skin in the face adjacent to lesions caused by actinic keratosis but not obviously affected themselves.
Conditions
Interventions
Trade Name: Klisyri® (Tirbanibulin)
Product Name: Klisyri
Pharmaceutical Form: Ointment
INN or Proposed INN: Tirbanibulin
Other descriptive name: Klisyri
Concentration unit: mg/g milligram(s)/gram
Con
Sponsors
Medizinische Universität Graz, Universitätsklinik für Dermatologie und Venerologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Informed consent (2) Diagnosed with sun-damaged skin on the face and AK in the treatment area (3) Willing and able to comply with all study procedures (4) Use of medically acceptable contraception in males or females of child-bearing potential (5) 51 -100 years of age (6) Negative pregnancy test at baseline in females of childbearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: (1) Allergy or intolerance towards the active ingredient or any of the constituents of the IMP (2) Any contraindication for the IMP, according to the most recent version of the SmPC (3) Open lesions of any kind on the face (4) Concomitant cutaneous malignancy in treatment area, including but not restricted to squa-mous skin cancer (5) Immune deficiency (6) Participation in another clinical trial during the last six months (7) Pregnancy or lactation (8) Excessive exposure to UV radiation during study period (9) Any contraindication against the use of UV imaging for diagnosis (10) Dependent on the sponsor / PI, e.g., as an employee (11) Unable or unwilling to understand the purpose of the study, or to comply with study-related procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is the unmasking of sub-clinical lesions in UV-exposed areas of chronically sun-damaged skin of the face by a treatment with Tirbanibulin.;Secondary Objective: oEfficacy of the treatment with Tirbanibulin oAssessment of the sun-damage skin after the treatment by UV photography (Canfield VISIA®);Primary end point(s): The primary endpoint of this study is total clearance (CIR) rates of unmasked lesions (57 ± 7 d) after the start of the treatment.;Timepoint(s) of evaluation of this end point: 57 ± 7 d after the start of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): o Percentage of patients with unmasked subclinical lesions at each visit o Partial clearance rates of unmasked lesions at 57 ± 7 d after the start of the treatment (FuV) o Quantification of skin findings (AK lesions, subclinical lesions, sun damage, local skin reaction [LSRs], and other changes of the skin, which are not necessarily clinically relevant) at each visit. Safety is analysed by means of adverse events. Local skin reactions are recorded and graded separately.;Timepoint(s) of evaluation of this end point: 57 ± 7 d after the start of the treatment | — |
Countries
Austria
Contacts
Public ContactDaisy Kopera
Medizinische Universität Graz Universitätsklinik für Dermatologie und Venerologie
Outcome results
None listed