Clinical efficacy and safety of sequential therapy with cryotherapy and topical tirbanibulin 1% in actinic keratoses in transplant recipients: a randomised clinical trial. - TIRTRASP

Clinica Universidad De Navarra0 个研究点目标入组 40 人开始时间: 2024年1月12日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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.

发起方

Clinica Universidad De Navarra