The objective of this study is to study the effectiveness of oral IMOD in the treatment of Oral Lichen Planus. In this randomized, double blind placebo-controlled trial, 40 patients with diagnosis of oral lichen planus lesion will be recruited. The patients will be randomly assigned into intervention or control groups. The patients in the intervention group will receive IMOD, 120mg capsules, 4 times a day for 3 months. The patients in the control groups will receive placebo with the same dosage. The outcome measures are Pain and burning sensation, Clinical grade of lesion, Oral TNF-α, Clinical Global Impression of Change (CGIC), and Patient Global Impression of Change (PGIC).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138801191559N2
Registration date:2010-12-21, 1389/09/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-21, 1389/09/30
Registrant information
Name
Farzaneh Aghahoseini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6611 2437
Email address
aghahose@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pars Roos Pharmaceutical Company
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-11-21, 1390/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomised Double Blind Placebo Controlled Trial of the Effect of Oral IMOD in Oral Lichen Planus
Public title
Assessing the effectiveness of IMOD in Oral Lichen Planus
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 64 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central Building, Ghods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Approval date
2010-12-21, 1389/09/30
Ethics committee reference number
1175/130/د/89
Health conditions studied
1
Description of health condition studied
Oral Lichen Planus
ICD-10 code
L43
ICD-10 code description
Lichen planus
Primary outcomes
1
Description
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
2
Description
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 outcomes
1
Description
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.
2
Description
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.
3
Description
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”
Intervention groups
1
Description
Placebo, 1 capsule every 6 hours, for 3 months
Category
Placebo
2
Description
IMOD, 120 mg (1capsule) every 6 hours for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Special clinic, Faculty of Dentistry, Tehran University of Medical Sciences