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Clinical efficacy and safety of sequential therapy with cryotherapy and topical tirbanibulin 1% in actinic keratoses in transplant recipients: a randomised clinical trial.
EU CTIS ID: 2023-508091-11-00
What this study is testing
To evaluate the efficacy of sequential treatment with cryotherapy and topical tirbanibulin (1%) for actinic keratosis (AK) in solid organ transplant (SOT) patients.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Solid organ transplant patients with AK
- Time elapsed since the transplant of at least one year.
- Stable immunosuppressive treatment for at least 6 months.
- Presence of 4 to 8 AKs in two symmetrical areas of 25 cm2 (in the contralateral facial area or scalp) susceptible to treatment.
- The patient must be 18 years or older.
- The patient, or his or her representative, has given consent to participate in the study.
You likely can't join if
- History of hypersensitivity to the active substances of the medication or any of its excipients.
- Use of oral retinoids, nicotinamide or oral capecitabine.
- Diagnosis or suspicion of EC in any of the areas to be treated
- Physical treatment (cryotherapy, curettage, electrosurgery, laser) or pharmacological treatment (chemical peels, photodynamic therapy, 5-fluorouracil, imiquimod, tirbanibulin) in the 3 months prior to inclusion in the trial.
- Women who are pregnant, lactating, or planning pregnancy during treatment with tirbanibulin. Once the treatment period has ended, pregnancy will not be a criterion for withdrawal from the study.
See the full eligibility criteria
- Solid organ transplant patients with AK
- Time elapsed since the transplant of at least one year.
- Stable immunosuppressive treatment for at least 6 months.
- Presence of 4 to 8 AKs in two symmetrical areas of 25 cm2 (in the contralateral facial area or scalp) susceptible to treatment.
- The patient must be 18 years or older.
- The patient, or his or her representative, has given consent to participate in the study.
- The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.
- In the case of women of childbearing potential, they must agree to use a safe means of contraception (abstinence is considered an acceptable method) for the entire treatment period and for at least one more month. A negative pregnancy test will be required on the selection date.
- History of hypersensitivity to the active substances of the medication or any of its excipients.
- Use of oral retinoids, nicotinamide or oral capecitabine.
- Diagnosis or suspicion of EC in any of the areas to be treated
- Physical treatment (cryotherapy, curettage, electrosurgery, laser) or pharmacological treatment (chemical peels, photodynamic therapy, 5-fluorouracil, imiquimod, tirbanibulin) in the 3 months prior to inclusion in the trial.
- Women who are pregnant, lactating, or planning pregnancy during treatment with tirbanibulin. Once the treatment period has ended, pregnancy will not be a criterion for withdrawal from the study.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.