The aim of this study is to observe the influence of tirbanibulin on proliferation patterns of actinic keratoses (efficacy on proliferation score according to Schmitz et al.). For this purpose, tirbanibulin is applied in-label, proliferation is measured by LC-OCT at different time points and dermatohistopathology is performed (optionally) at the end. Local skin reactions to the product will also be recorded (tolerability).
male, female, diverse patients (> 18yo) who are capable of giving consent
female patients are eligible if the patient is not a woman of childbearing potential (WOCBP) or if she is postmenopausal (cessation of menstruation >12 months) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, total hysterectomy)
signed informed consent
diagnosis of at least 1 non-hypertrophic, non-hyperkeratotic actinic keratosis of the scalp or face with Olsen Grade I and PRO II or III
known or documented intolerance to any of the ingredients of Klisyri®
any planned AK treatment other than Klisyri® in the treatment area
treatment of actinic keratoses in the treatment area within the past 3 Months (e.g. photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy etc.)
suspected invasive squamous cell cancer in the treatment area
Patients from the medical office (Berufsausübungsgemeinschaft Prof. Dr. Dirschka und Priv.-Doz. Dr. Schmitz).
Cohort
Prospective
Not listed
- Improvement of the PRO score of the marker lesion at D57 (LC-OCT) and/or clearance in LC-OCT of marker lesion at D57
Measurement will be done by LC-OCT to detect the PRO Score of the actinic keratosis.
assessment of local skin reaction grading scale at V2
Assessment of the local skin reaction via a 4-point-likert scaled measurement of erythema, scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration
Clinical clearance of marker lesion at visit 2
Clinical clearance of the previously marked actinic keratosis
Clinical clearance of marker lesion at visit 3
Clinical clearance of predefined actinic keratosis at visit 3
Improvement of PRO Score at V2
Improvement of PRO score at visit 2 in LC-OCT (line-field optical coherence tomography)
LC-OCT clearance of marker lesion at V2
Clearance of marker lesion at visit 2 in LC-OCT (line-field optical coherence tomography)
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Thomas Dirschka
Lead sponsor
CentroDerm GmbH
Sponsor institution
