Evaluation of the Additive Effect of Tamoxifen ointment 0.5% Intralesional Glucantim injection in Patients with Cutaneous Leishmaniasis: A Randomized triple-Blind Clinical Trial

Assessment of the Adjunctive Effect of Topical Tamoxifen Ointment on the Efficacy of Standard Glucantime Therapy in Patients with Cutaneous Leishmaniasis

randomized, triple-blind, parallel-group, controlled clinical trial involving 60 patients

A total of 60 patients with a confirmed diagnosis of cutaneous leishmaniasis, will be recruited from the dermatology clinics of Imam Reza Hospital, Hasheminejad Hospital, and affiliated health centers in Mashhad. After providing written informed consent, eligible participants will be enrolled in the study and randomly assigned to either the intervention group or the placebo group, with 30 patients allocated to each group. Random allocation will be performed using a block randomization method with a 1:1 allocation ratio.

Inclusion * Diagnosis of cutaneous leishmaniasis. * 18_60 years. * Absence of underlying conditions that contraindicate tamoxifen therapy (e.g., hypertension or unexplained vaginal bleeding). * Absence of significant systemic diseases, including uncontrolled diabetes mellitus and immunodeficiency disorders. Exclusion * Pregnancy or breastfeeding *allergy to ointment.

patients will be randomly assigned to either the intervention group or the placebo group. All participants will receive standard treatment with Glucantime according to the treatment protocol. participants will receive either topical tamoxifen ointment or placebo ointment throughout the treatment period.

Lesions in both groups will be assessed for size, induration, clinical improvement, local adverse effects, and recurrence at baseline, weeks 4, 8, and 12, and 3–6 months after treatment completion.

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.

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.