The aim of this study is the evaluation of the efficacy of methotrexate in treatment of lichen planus and use of this agent as a treatment of choice in some instance like in old ages or in the patients with diabetes or other conditions that systemic steroids are contraindicated. Twenty patients with generalized lichen planus after signing a detailed informed consent form will enroll in our study. Laboratory data's including blood counts, liver and kidney function tests will be collected at base line and photographs will be taken from all patients at first visit. The tests and photos will be repeated at 2nd, 4th, 8th week and 6th month after the beginning for evaluation of the response, compliance and adverse effects. Methotrexate (MTX), initiated at the dose of 7.5mg - 10 mg weekly , together with 1 mg folic acid daily except the day of MTX administration .the evaluation of treatment response is as follow: no response (<25%); mild response (25-75%); moderate response (50-75%) and excellent response (>75%). Inclusion criteria are: pathologically confirmed lichen planus and age between 18-75 while the exclusion criteria's are age less than 18 or more than 80 years old; pregnancy and lactation; chronic liver or kidney disease; use of systemic corticosteroids in last 6 month or application of topical steroids in last month and inability to come for follow up visits. Primary outcome measure is the rate of improvement of lichen planus
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108187287N1
Registration date:2011-08-18, 1390/05/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-08-18, 1390/05/27
Registrant information
Name
Farhad Malekzad
Name of organization / entity
Skin Research Center, Shohada-e-tajrish hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1507
Email address
a_panahi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Skin Research Center, Shohad-e-tajrish hospital, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of methotrexate in generalized lichen planus
Public title
Therapeutic effects of methotrexate in generalized lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pathologically confirmed lichen planus and age between 18-75. Exclusion criteria: age less than 18 or more than 80 years old; pregnancy and lactation; chronic liver or kidney disease; use of systemic corticosteroids in last 6 month or application of topical steroids in last month and inability to come for follow up visits.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Skin Research Center Ethic Committee
Street address
Shahid Beheshti University of Medical Sciences, Shohada-e- tajrish hospital