IRCT20260620069888N1 IRCT 2026-06-22 Mashhad University of Medical Sciences Evaluation of the Added Effect of 0.5% Topical Tamoxifen Ointment Concurrently with Intralesional Glucantime Therapy in Patients with Cutaneous Leishmaniasis Evaluation of the Additive Effect of Tamoxifen ointment 0.5% Intralesional Glucantim injection in Patients with Cutaneous Leishmaniasis: A Randomized triple-Blind Clinical Trial 2026-07-01 anticipated 60 Recruiting https://irct.ir/trial/91053 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization was employed in this study. Eligible cutaneous lesions were randomly assigned in equal numbers to two groups using blocks of four. To achieve this, 15 blocks of four were initially generated, with the random sequence within each block created using Microsoft Excel. The blocks were then randomly ordered without replacement, and participants were allocated to either Group A or Group B according to the predetermined sequence. This process continued consecutively until the required sample size was reached. Allocation concealment was ensured through the use of sealed, opaque envelopes containing the randomization sequence generated during the random allocation process. Based on the study sample size, a corresponding number of opaque envelopes were prepared. Each random allocation sequence was recorded on a card and placed inside an envelope. To preserve the randomization order, the envelopes were sequentially numbered on the outside according to the allocation sequence. Finally, all envelopes were sealed and remained unopened until participant assignment, Blinding description: Following enrollment, participants will be randomly allocated to one of two study groups using a block randomization table: 1. Intralesional Glucantime (meglumine antimoniate) + placebo ointment (ointment base) 2. Intralesional Glucantime (meglumine antimoniate) + 0.5% tamoxifen ointment in a petrolatum base Both ointments will be prepared in the laboratory of the Faculty of Pharmacology, Mashhad University of Medical Sciences. The formulations will be packaged with identical appearance and labeling codes to ensure concealment of treatment allocation. The study will be conducted as a triple-blind trial. Participants, the evaluating physician, and the data analyst will remain unaware of treatment assignments throughout the study period. 3 Cutaneous leishmaniosis. Intervention group: Treatment with topical tamoxifen ointment applied to the lesions twice daily, in combination with weekly intralesional Glucantime injections.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available