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IRCT20241208063991N1 IRCT 2025-05-16 Tehran University of Medical Sciences The effect of topical insulin on oral lichen planus Investigating the effect of topical insulin in comparison of placebo in the treatment of patients with oral lichen planus 2025-04-19 anticipated 38 Complete https://irct.ir/trial/81258 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: No, Randomization description: Randomization: Random assignment of patients to local normal saline group (A) and local insulin group (B) will be done through block randomization as follows. In this way, each individual will be considered as a block. Binary blocks will be constructed in such a way that the AB combination (A means local normal saline, B means local insulin) will be given to the right of the individual and the local insulin to the left. Similarly, the BA combination will be given to the right of the individual and the local normal saline to the left. To prepare the random list, a random number table will be used in such a way that a random number will be selected at each stage. If the selected number will be between 0 and 4, the AB combination will be considered, and if the selected number will be between 5 and 9, the BA combination will be considered. In addition, in this study, blocks of 4, 6, and 8 will be used randomly to prepare the random list, Blinding description: Both groups are given solutions without explanation of the type of solution, and the code is written as the letter A on the insulin solution and the letter B on the normal saline solution, which can be distinguished by the research team. Assignment to group A or B will be done based on a random table. 2 Oral Lichen planus. Intervention 1: Intervention group: 19 patients receive topical insulin, 1 cc of regular topical insulin, 2 units per cc, twice daily for 3 months. Patients will be visited monthly and lesion size will be measured in square centimeters and photographs will be taken. Control group: 19 patients receive topical normal saline. In the second group, topical normal saline will be applied twice daily for 3 months. Patients will be visited monthly and lesion size will be measured in square centimeters and photographs will be taken. Intervention 2: Control group: 19 patients will receive topical normal saline. In this group, topical normal saline will be applied to the lesions twice a day, one cc, for three months. Patients will be visited every month and the size of the lesion will be measured in square centimeters and a photograph will be taken of the patient. Yes - There is a plan to make this available What will be shared: Data for all variables is provided upon request When: Data will be available all the time on request To whom: Data will be available for academic institution Conditions: Data will be provided for other academic institution. Requests should be approved by Tehran University of Medical science Where to obtain: Tehran University of Medical Science How to obtain: The process of obtaining data involve the research center in tehran university of medical science/ dermatology department. Comments: no additional comments
public Ashid Mohamed
No 64, Khandan alley ,Vahdat-e-eslami street
Tehran Iran (Islamic Republic of) 1416753955 +98 910 752 7437 asheed.almohammadi94@gmail.com Tehran University of Medical Sciences scientific Asheed Mohamed
No 64, Khandan alley ,Vahdat-e-eslami street
Tehran Iran (Islamic Republic of) 1416753955 +98 910 752 7437 asheed.almohammadi94@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with a confirmed diagnosis of Oral Lichen Planus From any age group no limit no limit Both Diabetic patients Immunosuppressive patients Pregnant ladies L43.9 Lichen planus, unspecified Treatment - Drugs Placebo Intervention group: 19 patients receive topical insulin, 1 cc of regular topical insulin, 2 units per cc, twice daily for 3 months. Patients will be visited monthly and lesion size will be measured in square centimeters and photographs will be taken. Control group: 19 patients receive topical normal saline. In the second group, topical normal saline will be applied twice daily for 3 months. Patients will be visited monthly and lesion size will be measured in square centimeters and photographs will be taken. Control group: 19 patients will receive topical normal saline. In this group, topical normal saline will be applied to the lesions twice a day, one cc, for three months. Patients will be visited every month and the size of the lesion will be measured in square centimeters and a photograph will be taken of the patient. The size of oral lichen planus lesions. Timepoint: Measurement of oral lichen planus lesion size will be performed at the beginning of the study (before the intervention begins) and 1, 2, and 3 months later. Method of measurement: The size of the waste will be measured with a ruler (unit: centimeters). Tehran University of Medical Sciences Approved 2024-11-13 Ethics Committe of College of Medicine, Tehran University of Medical Science Razi Hospital, Vahdat-e- eslami streat, Shapour square, Tehran Tehran Tehran Iran (Islamic Republic of)