Oral Lichen Planus. Lichen planus
Conditions
Interventions
Intervention 1: Placebo, 1 capsule every 6 hours, for 3 months. Intervention 2: IMOD, 120 mg (1capsule) every 6 hours for 3 months.
Placebo
Treatment - Drugs
Placebo, 1 capsule every 6 hours, for 3 months
IMOD, 120 mg (1capsule) every 6 hours for 3 months
Sponsors
Pars Roos Pharmaceutical Company
Eligibility
Sex/Gender
Male
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Level of TNF-a in Saliva. Timepoint: Before and after the intervention. Method of measurement: To measure the TNF-a, 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-a 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”. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFarzaneh Aghahosseini
Tehran University of Medical Sciences
Outcome results
None listed