The objective of this study is to investigate the effect of methotrexate on patients with oral lichen planus. This study is a single-center, interventional, non randomized, non blinded study in which placebo will not be used. The participants in this study are patients with oral lichen planus who are referred to Razi Hospital. Inclusion criteria: patients with oral lichen planus, diagnosed by clinical and pathological criteria who did not respond to topical therapy.
Exclusion criteria: immunodeficiency; pregnancy; malignancy and adverse effects. The sample size is 15 patients. 7.5 mg methotraxate in the first week and 15 mg from the following week will be administered in condition of tolerance and the resolution of oral lesions is checked. 1mg folic acid per day will be administered too. treatment duration is 12 weeks. In each visit, each patient will be evaluated for leukopenia, anemia, thrombocytopenia, liver function and kidney function.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013121715655N2
Registration date:2014-06-27, 1393/04/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-27, 1393/04/06
Registrant information
Name
Vahide Lajevardi
Name of organization / entity
Razi Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 4403 3979
Email address
lajevardi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center of the skin and blister, Tehran University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assesment of the efficacy of methotrexate on patients with oral lichen planus
Public title
Effects of Methotrexate on oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with oral lichen planus, diagnosed by clinical and pathological criteria, who did not respond to topical therapy.
Exclusion criteria: Pregnancy and breast feeding; cancer; severe and frequent infections; Hereditary or acquired immunodeficiency; leukopenia; anemia; thrombocytopenia; hepatic dysfunction; Stomach ulcers; dysplastic lesions in pathology; ulcerative colitis disease; side effects of methotraxate
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee at Tehran University of Medical Sciences
Street address
Central Organization of Tehran University of Medical Sciences, Ghods st, Keshavarz blvd, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-09-01, 1391/06/11
Ethics committee reference number
91/د/ 130/1174
Health conditions studied
1
Description of health condition studied
lichen planus
ICD-10 code
L43.8
ICD-10 code description
Other lichen planus
Primary outcomes
1
Description
The resolution of oral lesions
Timepoint
Before treatment and at two, four, eight and twelve weeks
Method of measurement
Thongprasom Scale
2
Description
Pain reduction
Timepoint
Before treatment and at weeks two, four, eight and twelve
Method of measurement
VAS ( Visual Analog Scale) Pain was scored from zero to ten
Secondary outcomes
1
Description
The side effects of methotraxate
Timepoint
First, fourth, eighth and twelfth week
Method of measurement
Examination in each visit
2
Description
The Size of lesions
Timepoint
First, fourth, eighth and twelfth week
Method of measurement
Transparent grid ( mm )
3
Description
Duration of disease since diagnosis
Timepoint
Before treatment
Method of measurement
Interview
4
Description
the type of lesion (ulcerative , reticular , atrophic)
Timepoint
Before treatment
Method of measurement
previous records
5
Description
The location of lesions (bucal , gingival , palatine)
Timepoint
Before treatment
Method of measurement
previous records
Intervention groups
1
Description
In this study, in the first week, 7.5 mg methotraxate per week (three tablets, 2.5 milligrams) plus 1mg folic acid per day will be administered and from the next week, 15 mg per week plus 1mg folic acid per day in condition of tolerance will be administered. Treatment duration is 12 weeks. In each visit, each patient will be evaluated for leukopenia, anemia, thrombocytopenia, liver function and kidney function.