This study evaluates the effect of Imod on decreasing sign and symptom of oral lichen planus lesion. It is an open-labeled, before-after study enrolling 25 patients (60 lesions) with clinical and histopathologic diagnosis of lichen planus. They are selected among the persons, presenting to the Oral Medicine Department at the Dentistry faculty in Tehran University of Medical Sciences (TUMS). Patients with systemic disease, pregnancy and any other mucosal lesions were excluded from the study. Patients received daily IMOD capsules for 90 days. The patients were examined 2 weeks, 4 weeks, 2 months, 3 months, 4 months, 5 months and 6 months after receiving the first capsule. During these sessions they asked for pain and burning sensation. The scores of the lesions were also recorded each time, based on clinical examination by researcher. Data associated with pain and burning sensation was measured, by "visual analogue scale". Measuring the level of TNF-alfa before and after using the drug is a good index for drug efficiency. TNF-alfa would be examined in the unstimulated accumulated saliva of patients. It should be done before begining of treatment and 3 months after it.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710291559N1
Registration date:2010-01-09, 1388/10/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-01-09, 1388/10/19
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
Tehran University of Medical Siences
Expected recruitment start date
2008-03-05, 1386/12/15
Expected recruitment end date
2008-12-06, 1387/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of IMOD effect on oral lichen planus
Public title
Evaluation of IMOD effect on oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: clinical histopathologic diagnosis of lichen planus (Lichen planus diagnosis will be made with clinical criteria, consisting of the presence of symmetric reticular or papular lesions with or without erosive/atrophic or Bullous components. Histopathologic features of oral lichen palnus are: 1) Areas of hyperparakeratosis or hyperorthokeratosis, often with a thickening of the granular cell layer and a saw-toothed appearance to the retepages. 2) Liquefaction degeneration or necrosis of the basal layer. 3) A dense subepithelial band, shaped by infiltration of lymphocytes and macrophages. 4) Absence of dysplastic changes)
Exclusion criteria: Any systemic disease, pregnancy and any other mucosal lesions
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Dental Research Center
Street address
Dentistry faculty, Tehran University of Medical Sciences
City
Tehran
Postal code
7529
Approval date
2017-11-21, 1396/08/30
Ethics committee reference number
1382/130/ص/88
Health conditions studied
1
Description of health condition studied
Lichen planus
ICD-10 code
L-43
ICD-10 code description
Primary outcomes
1
Description
Clinical score
Timepoint
2 weekly in the first month and then monthly for 6 months
Method of measurement
regesteration the primary scores of lesions and their changes on the follow up period as described in the matherial and methods
Secondary outcomes
1
Description
Pain and discomfort in the oral lesion
Timepoint
2 weekly in the first month and then monthly up to 6 month
Method of measurement
VAS scale as described in the matherial and method
Intervention groups
1
Description
IMOD 400 mg daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral medicine department of Tehran University of Medical Siences
Full name of responsible person
Dr Aghahosseini - Dr Neda Akbary
Street address
Oral medicine department -Dentistery faculty of Tehran university-Ghods Ave.Keshavarz Blvd.Tehran .Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center of dental Science of Tehran University of medical sciences
Full name of responsible person
Dr Azam khorshidian
Street address
Research center of dental sience of tehran university-Ghods Ave-Keshavarz Blvd-tehran-Iran
City
Tehran
Grant name
در اختیار دانشگاه علوم پزشکی تهران
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center of dental Science of Tehran University of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Oral Medicine Department of Tehran University of Medical Siences
Full name of responsible person
Dr Neda Akbary Gillani
Position
Resident of oral medicine
Other areas of specialty/work
Street address
Oral medicine department of Tehran University of Medical Sience- ghods Aven-Keshavarz Blvd-Tehran-Iran
City
Tehran
Postal code
Phone
+98 21 2232 2825
Fax
Email
nedaakbary@gmail .com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oral medicine department of Tehran University of Medical Sience
Full name of responsible person
Dr Farzaneh Aghahoseini
Position
Professor
Other areas of specialty/work
Street address
Oral medicine department of Tehran University of Medical Sience-Ghods Aven-Keshavarz Blvd-Tehran-Iran
City
Tehran
Postal code
Phone
+98 21 2256 6471
Fax
+98 21 6640 1132
Email
aghahose@ sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)