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IRCT20250630066310N1 IRCT 2025-07-30 Mashhad University of Medical Sciences effect of formulated methylene blue basal cell carcinoma (BCC) Evaluation of the effect of formulated methylene blue basal cell carcinoma (BCC) 2025-06-26 anticipated 20 Complete https://irct.ir/trial/84706 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2-3 Basal Cell Carcinoma. Intervention group: Intervention group: Methylene blue 0.5mg/ml solution and formulated ointment are applied topically on the patient's BCC lesion every two days for a month and the lesion is photographed. If the wound improves and shrinks, the same procedure will continue until complete healing, and if there is no improvement after one month, standard methylene blue photodynamic therapy will be applied for another month.. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more data
public Mahdi Razmara
Daneshgah street
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3858 3845 razmarafm@mums.ac.ir Mashhad University of Medical Sciences scientific Mahdi Razmara
Daneshgah street
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3858 3845 razmarafm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Informed and written consent of the patient to participate in the study. Diagnosis of basal cell carcinoma of the skin confirmed by pathology. Patient unwillingness to undergo surgery or inability to undergo surgery or inability to administer intralesional medical treatment such as interferon alpha or 5-FU. Age 18 years and older. Lesion size less than 2 cm. Superficial and nodular form of BCC Multiple lesions 18 years no limit Both Basal cell carcinoma of the skin of the morphea-like and nodular ulcerative type Pregnancy and lactation. History of serious drug-related complications. Failure to complete the course of treatment. Failure to refer for follow-up treatment. History of cardiovascular diseases. History of thromboembolic diseases. Radiotherapy treatment in the relevant area Contact with arsenic. Weak immunity. Presence of serious systemic disease. Having a history of allergy or sensitivity to methylene blue. Having a history of bleeding disorders or abnormal blood clotting. Having a history of severe skin disorders or inflammation in the treatment area C44.310 Basal cell carcinoma of skin of unspecified parts of face Treatment - Drugs Intervention group: Intervention group: Methylene blue 0.5mg/ml solution and formulated ointment are applied topically on the patient's BCC lesion every two days for a month and the lesion is photographed. If the wound improves and shrinks, the same procedure will continue until complete healing, and if there is no improvement after one month, standard methylene blue photodynamic therapy will be applied for another month. Primary Outcome of Complete Wound Repair After 2 Months of Treatment Initiation Based on Dermoscopic Results and Clinical Repair. Timepoint: Methylene blue 0.5mg/ml solution and formulated ointment are applied topically to the lesion every two days for a month and the lesion is photographed. If the wound improves and shrinks, the same procedure is continued until complete healing, and if there is no improvement after one month, standard methylene blue photodynamic therapy is applied for another month. Method of measurement: Outcomes are evaluated by measuring changes in lesion size, examining tissue repair, clinical and dermoscopic imaging. The secondary outcome of the absence of ulcer recurrence after 6 months of patient follow-up. Timepoint: After the four stages of treatment, wound repair ointment will be applied to speed up the healing process. Method of measurement: Outcomes are evaluated by measuring changes in lesion size, examining tissue repair, clinical and dermoscopic imaging. Also, if the patient agrees, tissue sampling will be used to evaluate pathology. Mashhad university of medical sciences Approved 2025-06-25 Ethics committee of Mashhad university of medical sciences Dermatology clinic of Imam Reza hospital Mashhad Razavi Khorasan Iran (Islamic Republic of)