RecruitingNCT06648447

Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns

Sponsor

Thomas Dirschka

Enrollment

20 participants

Start Date

Oct 22, 2024

Study Type

OBSERVATIONAL

Conditions

Actinic Keratosis (AK)

Summary

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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
planned treatment of AK with Klisyri® before study start and indepently of the study
the study participant is in good general condition for his or her age and does not currently have any active diseases that, in the opinion of the investigator, justify exclusion from the study

Exclusion Criteria17

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
chronic wounds, erosions, pre-existing inflamed or infected skin with disruption of the epidermal barrier in the treatment area
suspected non-compliance
current or within the last 8 weeks given systemic cancer medication
any other topical treatment against actinic keratosis in the treatment area within the past 12 weeks
any contraindication according to the Summary of Product Characteristics (SmPC) of Klisyri®
any systemic immunosuppressant given within the 8 weeks prior to the study (e.g. systemic prednisolone, azathioprine etc.)
locally applied retinoids, steroids, or other prescribed externals in the 4 weeks prior to the start of the study in the treatment area that, in the opinion of the study physician, necessitate exclusion
products containing glycolic or alpha-hydroxy acids applied locally in the treatment area in the last 4 weeks
chemical peelings in the treatment area in the last 4 weeks
simultaneous participation in a clinical trial
participation in a clinical study within the last 30 days
family members or colleagues of the investigator or the investigational team or the CRO
patient is in a position or has a relationship with the investigator that presents a potential conflict of interest