Objective: The aim of this study is comparison of efficacy between methotrexate vs. hydroxychloroquine on activity of lichen planopilaris. 2) Design: This study is a randomized clinical trial. 3) Setting and conduct: The patients with lichen planopilaris in dermatology clinic will be randomly divided into two groups (15 patients in methotrexate group and 14 ones in hydroxychloroquine group). 4) Intervention: After taking consent, methotrexate (15 mg/week) in one group and hydroxychloroquine sulfate (400 mg/day) in the other one will be administered for 6 months. 5) Main outcome measures: Lichen planopilaris activity index (LPPAI) will be calculated and standardized global photography will be taken in all patients. Then, the aforementioned indices and the efficacy of medications after the intervention will be compared between the groups. 6) Participants: Inclusion criteria: Scalp involvement> 10% and no response to the previous 3-month topical or 6-month systemic medications; In the case of local involvement (<10% of scalp), resistance to the combination of topical and at least 6-month systemic therapy; the patients should be stopped all systemic medications at least 1 month before enrollment to the study. Exclusion Criteria are as follow: pregnancy or lactation; Hb<9 mg/dl; WBC< 4000; platelet< 100000; liver enzymes> 2 times of upper limit of normal; and positive viral hepatic markers. Withdrawal criteria include no show up in follow-up visits; discontinuing the medication by patient; administration of another immunosuppressive or topical medication by other physician
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062822959N1
Registration date:2015-08-19, 1394/05/28
Registration timing:na
Last update:
Update count:0
Registration date
2015-08-19, 1394/05/28
Registrant information
Name
Mina Saber
Name of organization / entity
Isfahan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 5414
Email address
m_saber@mail.mui.ac.ir
Recruitment status
Not enough for processing
Funding source
This research was supported and funded by Isfahan University of Medical Sciences(Code: 392118).
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
empty
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of methotrexate versus hydroxychloroquine on disease activity index in patients with lichen planopilaris
Public title
The effect of methotexate and hydroxychloroquine on lichen planopilaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Scalp involvement> 10% and no response to the previous 3-month topical or 6-month systemic medications; In the case of local involvement (<10% of scalp), resistance to the combination of topical and at least 6-month systemic therapy; the patients should be stopped all systemic medications at least 1 month before enrollment to the study.
Exclusion Criteria are as follow: pregnancy or lactation; Hb<9 mg/dl; WBC< 4000; platelet< 100000; liver enzymes> 2 times of upper limit of normal; and positive viral hepatic markers.
Withdrawal criteria include no show up in follow-up visits; discontinuing the medication by patient; administration of another immunosuppressive or topical medication by other physician.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib street, Isfahan, Iran
City
Isfahan
Postal code
73461-8147
Approval date
2015-02-25, 1393/12/06
Ethics committee reference number
394165
Health conditions studied
1
Description of health condition studied
Lichen planopilaris
ICD-10 code
L66.1
ICD-10 code description
Follicular lichen planus
Primary outcomes
1
Description
Lichen planopilaris activity index
Timepoint
Before and after intervention
Method of measurement
Checklist
2
Description
Standardized global photpgraphy
Timepoint
Before and after intervention
Method of measurement
Based on scoring by two deramtologist
Secondary outcomes
empty
Intervention groups
1
Description
Methotrexate (15 mg/week orally, in one day) will be administered in one group (15 patients) and for 6 months.
Category
Treatment - Drugs
2
Description
Hydroxychloroquine sulfate (Two tablets daily that is equivalent to 400 mg) administered in the other group (14 patients) for 6 months