Actively Recruiting
Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns
Led by Thomas Dirschka · Updated on 2025-07-09
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to observe how tirbanibulin affects the growth patterns of actinic keratoses (AK), which are precancerous skin changes often caused by UV exposure. The study focuses on using a special score called the PRO score to measure cell proliferation in these lesions. Actinic keratoses are common and can be challenging to treat due to their tendency to persist or recur. This study evaluates tirbanibulin's role in treating AK with specific cell growth patterns and monitors local skin reactions to assess tolerability. Participants will apply tirbanibulin topically according to its approved use. The treatment involves five consecutive applications, which is considered quick and generally causes minor local reactions. Proliferation and clearance of the lesions will be measured using an imaging technique called line-field optical coherence tomography (LC-OCT) at different time points, including 14 days and 70 days after treatment start. Optionally, tissue samples may be examined after treatment to further assess histological changes. During the study, participants will be assessed for changes in the PRO score and lesion clearance through LC-OCT and clinical evaluations at scheduled visits. Skin reactions will also be recorded to understand the treatment's tolerability. The main outcome is the improvement or clearance of the marker lesion 70 days after inclusion. The study lasts about 70 days, with key evaluations at 14 and 70 days after starting treatment, ensuring thorough monitoring of treatment effects and safety.
CONDITIONS
Brief Title
Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, female, diverse patients over 18 years old who can give consent
- Female participants must not be of childbearing potential or must be postmenopausal or surgically sterile
- Signed informed consent is required
- Diagnosis of at least one non-thickened, non-scaly actinic keratosis on scalp or face with Olsen Grade I and PRO Score II or III
- Planned treatment with Klisyri® (tirbanibulin) before study start independently of study
- Participant is in good general health for their age without active diseases justifying exclusion
You will not qualify if you...
- Known intolerance to any ingredient of Klisyri®
- Planned treatment other than Klisyri® in the treatment area
- Treatment of actinic keratosis in the treatment area within past 3 months
- Suspected invasive squamous cell carcinoma in the treatment area
- Chronic wounds, erosions, inflamed or infected skin disrupting the epidermal barrier in treatment area
- Suspected non-compliance
- Systemic cancer medication within last 8 weeks
- Other topical actinic keratosis treatments in treatment area within past 12 weeks
- Contraindications according to Klisyri® product characteristics
- Systemic immunosuppressants within 8 weeks before study
- Locally applied retinoids, steroids, or other prescribed externals in treatment area within 4 weeks prior
- Use of products containing glycolic or alpha-hydroxy acids in treatment area within last 4 weeks
- Chemical peeling in treatment area within last 4 weeks
- Simultaneous participation in another clinical trial
- Participation in clinical study within last 30 days
- Family members or colleagues of investigator or study team
- Relationships presenting potential conflict of interest with investigator or study team
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 70 days after baseline
Participants who undergo routine care with tirbanibulin are observed to assess treatment effects on actinic keratoses using non-invasive imaging.
3 visits: baseline, 14 days after baseline, and 70 days after baseline
Trial Site Locations
Total: 1 location
1
CentroDerm
Wuppertal, North Rhine-Westphalia, Germany, 42287
Actively Recruiting
Research Team
T
Thomas Dirschka, Prof. Dr. med.
M
Marcus Kuchner, Dr. med.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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