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IRCT138801191559N2 IRCT 2010-12-21 Pars Roos Pharmaceutical Company Assessing the effectiveness of IMOD in Oral Lichen Planus Randomised Double Blind Placebo Controlled Trial of the Effect of Oral IMOD in Oral Lichen Planus 2010-11-22 anticipated 40 Complete https://irct.ir/trial/965 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The patients will be allocated to the intervention or control group using a separate complete block randomisation method. Blocks of 4 will be used for this purpose. Randomisation will not be exposed to those conducting the study and will be provided in closed letters with successive numbers. The envelope will be opened when a patient is going to join the study. 3 Oral Lichen Planus. Intervention 1: Placebo, 1 capsule every 6 hours, for 3 months. Intervention 2: IMOD, 120 mg (1capsule) every 6 hours for 3 months.
public Farzaneh Aghahosseini
Faculty of Dentistry, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) +98 21 2256 6471 aghahose@ sina.tums.ac.ir Tehran University of Medical Sciences scientific Farzaneh Aghahosseini
Faculty of Dentistry, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) +98 21 2256 6471 aghahose@ sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria: Presence of oral lesions of oral Lichen Planus, Clinical diagnosis of oral lesions: i.e. bilateral or symmetrical reticular lesions with or without atrophic erosive or bolus lesions, Presence of microscopic diagnostic criteria of Lichen Planus: i.e. increase in keratinisation with increase in thickness of granular cell, hydropic degeneration of basal layer, sub-epithelial infiltration of T lymphocytes, no dysplasia), Age 18 - 64 Exclusion criteria: Presence of dysplasia in histopathological view, Presence of lesion close to the amalgam filling, Presence of significant systematic disorder, History of local or systematic therapy during a month prior to the study, Pregnancy or intention of becoming pregnant during the study period (6 months), Breastfeeding, Inability to give informed consent according to the agreed process, Any drug hypersensitivity, Receiving radiotherapy, chemotherapy or any immunosuppressive drug 18 years 64 years Male L43 Lichen planus Placebo Treatment - Drugs Placebo, 1 capsule every 6 hours, for 3 months IMOD, 120 mg (1capsule) every 6 hours for 3 months Pain and burning sensation. Timepoint: Baseline and every other week during the first month and every month during the next five month. Method of measurement: Intensity of pain and burning sensation during the previous week will be measured mainly through a 5-point rating numerical scale from no pain to very severe pain. 0 = no pain or burning sensation 1 = mild pain or burning sensation 2 = moderate pain or burning sensation 3 = severe pain or burning sensation 4 = very severe pain or burning sensation. Clinical grade of the lesion. Timepoint: Baseline and every other week during the first month and every month during the next five month. Method of measurement: The oral lesions will be clinically graded based on the following grading scale: 0 = normal mucosa without lesion, 1 = reticular lesion with atrophic area less than 1 centimeter, 2 = reticular lesion with atrophic area more than 1 centimeter 3 = reticular lesion with erosive area less than 1 centimeter 4 = reticular lesion with erosive area more than 1 centimeter. Level of TNF-α in Saliva. Timepoint: Before and after the intervention. Method of measurement: To measure the TNF-α, the saliva will be collected from the patients without stimulation between 9:00 and 12:00 in the morning. The patients will be asked to pure their saliva in a pot every 60 minutes for 5-15 minutes until the volume reach to at least 2 cc. TNF-α will be measured in the saliva by using ELISA method. Clinical Global Impression of Change (CGIC). Timepoint: Every other week during the first month and every month during the next five month. Method of measurement: Through a 10-point scale on which the clinician rates the change observed in the patient’s overall status since the beginning of the study. Patient Global Impression of Change (PGIC). Timepoint: At the end of the treatment. Method of measurement: Through a 10-point scale on which patients themselves rate any changes observed in their overall status since the beginning of the study. The scores on this scale varies from “much improved” to “much worse”. Pars Roos Pharmaceutical Company Approved 2010-12-21 Ethics committee of Tehran University of Medical Sciences Central Building, Ghods St., Keshavarz Blvd., Tehran, Iran Tehran Iran (Islamic Republic of)