NCT06648447 Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns
| NCT ID | NCT06648447 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Thomas Dirschka |
| Condition | Actinic Keratosis (AK) |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2024-10-22 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06648447 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Actinic Keratosis (AK). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06648447 currently recruiting?
Yes, NCT06648447 is actively recruiting participants. Contact the research team at T.dirschka@centroderm.de for enrollment information.
Where is the NCT06648447 trial being conducted?
This trial is being conducted at Wuppertal, Germany.
Who is sponsoring the NCT06648447 clinical trial?
NCT06648447 is sponsored by Thomas Dirschka. The trial plans to enroll 20 participants.