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IRCT20200425047195N1 IRCT 2020-12-07 Esfahan University of Medical Sciences Effects of two mucoadhesive forms of Clobetasol on oral lichen planus Laboratory Indexes and Therapeutic Effects of Two Mucoadhesive Systems Containing Clobetasol on Oral Lichen Planus 2020-09-26 anticipated 44 Complete https://irct.ir/trial/47635 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of quadruple blocks: size of the blocks is randomly selected. In each block, there is an equal number from each group. In quadruple blocks, two case groups and two control groups are considered, Blinding description: In this study, two mucoadhesive forms of Clobetasol will be compared. The drug forms are simulated and therefore participants of the study will have no information about the two drug forms. 3 Oral lichen planus. Intervention 1: Intervention group: 1. Consumables specifications: mucoadhesive gel clobetasol RDN 0.05%. Chemical composition and concentration: each 100 mg contains 50 mg Clobetasol Propionate. Drug consumption time: rubbed on the region four times a day. Duration of drug use: one month. Intervention 2: Intervention group: 2. Consumables specifications: mucoadhesive Clobetasol Gel 0.05% made by Pharmaceutics. Chemical composition and concentration: each 100 mg contains 50 mg Clobetasol Propionate. Drug consumption time: rubbed on the region four times a day. Duration of drug use: one month. 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 decision has been made yet
public Faezeh Khozeimeh
Bagh Borj Complex, Bagh Borj Alley, Moshtaq St.
Isfahan Iran (Islamic Republic of) 8158836341 +98 31 3267 5638 Khozeimeh@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Faezeh Khozeimeh
Bagh Borj Complex, Bagh-e-Borj Alley, Moshtaq St.
Isfahan Iran (Islamic Republic of) 8158836341 +98 31 3267 5638 Khozeimeh@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of oral lichen planus according to clinical criterias and histopathology The age range: 16-70 years old Non-use of local or systemic drugs to treatment of lichen planus (one week before start of the study) Severity of lesions with 3, 4, and 5 scores according to Thongprasom index Non-use of immunosuppressive drugs (one week before start of the study) Non-use of drugs which cause lichenoid reaction (one week before start of the study) 16 years 70 years Both Pregnancy and breastfeeding Use of drugs which cause lichenoid reaction Use of immunosuppressive drugs Existence of any systemic disease other than lichen planus (example: viral, bacterial, and fungal infections; acute peptic ulcer; acute glomerulonephritis; myasthenia gravis) Existence of lesions in direct contact with amalgam-treated teeth Allergy to corticosteroids L43 Lichen planus Treatment - Drugs Treatment - Drugs Intervention group: 1. Consumables specifications: mucoadhesive gel clobetasol RDN 0.05%. Chemical composition and concentration: each 100 mg contains 50 mg Clobetasol Propionate. Drug consumption time: rubbed on the region four times a day. Duration of drug use: one month. Intervention group: 2. Consumables specifications: mucoadhesive Clobetasol Gel 0.05% made by Pharmaceutics. Chemical composition and concentration: each 100 mg contains 50 mg Clobetasol Propionate. Drug consumption time: rubbed on the region four times a day. Duration of drug use: one month. Pain intensity. Timepoint: Evaluation of pain intensity at start of the study, and at the first, second, third and fourth weeks after use of mucoadhesive Clobetasol. Method of measurement: Visual scale of pain. Size of erosive and atrophic areas of oral lichen planus. Timepoint: Evaluation of pain intensity at start of the study, and at the first, second, third and fourth weeks after use of mucoadhesive Clobetasol. Method of measurement: Thongprasom index. Life quality. Timepoint: Evaluation of life quality at start of the study, and at the first, second, third and fourth weeks after use of mucoadhesive Clobetasol. Method of measurement: Questionnaire of chronic oral mucosal diseases. Esfahan University of Medical Sciences Approved 2020-09-26 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib St. Isfahan Isfehan Iran (Islamic Republic of)