The aim of this study is comparison of efficacy between methotrexate vs. cyclosporine on activity of lichen planopilaris.
Design
A phase two randomized clinical trial,two parallel groups taking two different types of drugs(cyclosporine and methotrexate),each group 16 patients and total sample size is 32
Settings and conduct
After taking consent of patients who attend to the clinic and have inclusion criteria ,they randomly divided to two groups , in each group they start to take drugs for six months,and they will be visited in regular intervals.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Scalp involvement more than 10%, Local disease (<10%Involvement) resistant to topical or systemic treatment; Exclusion criteria:pregnancy lactation, Hb<9mg/dl, wbc<4000, plt<100000, liver enzymes 3 times more than upper limit of normal, positive viral hepatic tests, renal failure, uncontrolled blood pressure,administration of another immunosuppressive or topical medication by other physicians, elevated serum creatinine
Intervention groups
After taking consent,methotraxate (15mg/week) in one group and cyclosporine ( max300 mg /day) in other one will be administered for 6 months.
Main outcome variables
Lichen planopilaris activity index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190717044256N1
Registration date:2019-08-30, 1398/06/08
Registration timing:registered_while_recruiting
Last update:2019-08-30, 1398/06/08
Update count:0
Registration date
2019-08-30, 1398/06/08
Registrant information
Name
Minoo Jelvan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
minoo.jelvan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of methotrexate versus cyclosporine on disease activity index in patients with lichen planopilaris
Public title
The effect of methotrexate and cyclosporine on lichenplanopilaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Scalp involvement more than 10%
Local disease (<10%Involvement) resistant to 3-month topical treatment or 6-months systemic treatment
The patients should be stopped all systemic or topical medications at least one month before enrollment to the study
Exclusion criteria:
Pregnancy lactation
Hb<9mg/dl
Wbc<4000
Plt<100000
Liver enzymes 3 times more than upper limit of normal
Positive viral hepatic tests
Renal failure
Uncontrolled blood pressure
Administration of another immunosuppressive or topical medication by other physicians
Elevated serum creatinine >50% or >25% by lower doses of drug(25-50% over 2weeks)
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
patients who have inclusion criteria randomly are divided between two groups ; randomly the first patient belongs to the first group for taking cyclosporine and the second one starts to take methotrexate in second group. Theretofore the end of the study they will be divided between two groups one- to -one insofar each group reaches to 16 patients
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
Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-05-30, 1397/03/09
Ethics committee reference number
IR.MUI.MED.REC.1397.068
Health conditions studied
1
Description of health condition studied
Lichen planopilaris
ICD-10 code
L66.1
ICD-10 code description
Lichen planopilaris
Primary outcomes
1
Description
Lichen planopilaris activity
Timepoint
Before and after 2,4,6 months after intervention
Method of measurement
Checklist of criteria in lichen planopilaris activity index ; Lichen planopilaris activity index is measured by this formula:LPPAI = (itch + pain + burn ) / 3 + (scalp erythema + perifollicular erythema +perifollicular scale) / 3 + 2.5(pull test) + 1.5(spreading / 2)
2
Description
Standardized global photography
Timepoint
Before and after intervention
Method of measurement
Based on scoring by two dermatologists
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Methotrexate(15mg/week orally,in one day) will be administered in one group(16 patients) for six months
Category
Treatment - Drugs
2
Description
Intervention group: Cyclosporine( 300mg/day orally),will be administered in one group(16 patients)for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Minoo Jelvan,MD
Street address
Sofe street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Derm@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Shaghayegh Haghjoo
Street address
vice chancellor for Research ,Isfahan unicersity of medical Sciences,Hezarjarib street,Isfahan,Iran
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Minoo Jelvan,MD
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology, Alzahra hospital, Sofe street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Minoo.jelvan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Minoo Jelvan, MD
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology, Alzahra hospital, Sofe street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174645731
Phone
+98 31 3620 2020
Email
Minoo.jelvan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Minoo Jelvan,MD
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Sofe street,Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Minoo.jelvan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
In our research enough and appropriate information about patient's demographic data , analysis of before and after indices of LPPAI and global standardized photography will be published as our clinical report .