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
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 patients eligible if not women of childbearing potential, or if postmenopausal for over 12 months, or surgically sterile
- Signed informed consent obtained
- Diagnosis of at least one non-hypertrophic, non-hyperkeratotic actinic keratosis on the scalp or face with Olsen Grade I and PRO II or III
- Planned treatment of actinic keratosis with Klisyri before study start and independently of the study
- Participant is in good general condition for their age without active diseases justifying exclusion according to investigator
You will not qualify if you...
- Known or documented intolerance to any ingredients of Klisyri
- Planned actinic keratosis treatment other than Klisyri in the treatment area
- Actinic keratosis treatment in the treatment area within past 3 months (e.g., photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy)
- Suspected invasive squamous cell cancer in the treatment area
- Chronic wounds, erosions, inflamed or infected skin with epidermal barrier disruption in the treatment area
- Suspected non-compliance
- Current or past 8 weeks systemic cancer medication
- Any other topical actinic keratosis treatment in the past 12 weeks in the treatment area
- Any contraindication per Klisyri's Summary of Product Characteristics
- Systemic immunosuppressants within 8 weeks prior to study
- Locally applied retinoids, steroids, or other prescribed topical treatments in the 4 weeks before study start in the treatment area
- Products with glycolic or alpha-hydroxy acids applied locally in the last 4 weeks
- Chemical peelings in the treatment area in last 4 weeks
- Simultaneous participation in another clinical trial
- Participation in a clinical study within last 30 days
- Family members or colleagues of investigator, investigational team, or CRO
- Participant has a relationship with investigator presenting a potential conflict of interest
AI-Screening
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Trial Site Locations
Total: 1 location
1
CentroDerm
Wuppertal, North Rhine-Westphalia, Germany, 42287
Actively Recruiting
Research Team
T
Thomas Dirschka, Prof. Dr. med.
CONTACT
M
Marcus Kuchner, Dr. med.
CONTACT
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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