Assessing the effectiveness of Methotrexate versus Azathioprine on disease activity index in Lichenplanopilaris patients
Design
Randomized double-blinded parallel clinical trial
Settings and conduct
All patients with diagnosis of Lichen planopilaris and meeting inclusion and exclusion criteria, referring to dermatology clinic, Alzahra University-affiliated Hospital of Isfahan. Each group will start its treatment and then will be assessed for cure and side effects 2, 4, and 6 months later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with local disease that does not respond to topical treatment after one month
Patients with extensive scalp involvement as the first line treatment.
Patients should have discontinued any previous systemic medication 1 month prior to admission to the study.
ages 18-65
Exclusion criteria: Pregnancy or lactation
Leukocytes less than 3000 (leukopenia)
Platelets less than 100000
Hemoglobin less than 9
Liver enzymes more than 2 time the reference limit
Positive for viral hepatitis tests
Consumption of Allopurinol
Intervention groups
A group of 16 patients treating with Methotrexate 15 mg/week; a group of 16 patients treating with Azathioprine 2 mg/kg/day
Main outcome variables
Lichen planopilaris activity index score; Dermoscopy score; Photography score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191006045005N2
Registration date:2021-03-29, 1400/01/09
Registration timing:prospective
Last update:2021-03-29, 1400/01/09
Update count:0
Registration date
2021-03-29, 1400/01/09
Registrant information
Name
Parisa Hajheidarii
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3236 5742
Email address
parisahajheidarii@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of Methotrexate versus Azathioprine on disease activity index in Lichen planopilaris patients
Public title
Assessing the effectiveness of Methotrexat versus Azathioprine on disease activity index in Lichen planopilaris patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with local disease that does not respond to topical treatment after one month
Patients with extensive scalp involvement as the first line treatment.
Patients should have discontinued any previous systemic medication 1 month prior to admission to the study.
Ages 18-65
Exclusion criteria:
Pregnancy or lactation
Leukocytes less than 3000 (leukopenia of any etiology)
Platelets less than 100000
Hemoglobin less than 9
Liver enzymes more than 2 time the reference limit
Positive for viral hepatitis tests
Consumption of Allopurinol
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are allocated into either the intervention or control group using a non-stratified block randomization method to keep an even randomization ratio of (1:1). Random Allocation Software is used by our expert analytics to determine the list and group of patients. He is blinded to the selection process and pre-and post-operative assessments. The block size will be equal and is set to 4, the sufficient and estimated sample size will be 32, then the allocation code is set to sequential. The analytics will use the output of software to determine the sequence and allocation of patients. Then each code is written on a non-transparent envelope and a paper is put in it in which the intervention or control is written on the paper. The series of the envelope will be according to the software's list and they will keep in a large box with a locker. The analytics has the key for the box and this box will be kept in his room which the analytics has its only key and has no windows. As the patients enrolled in the study sequentially, the analytics use the designated envelope. The mechanism of randomization and block size will not be revealed to the principal investigator and other involved physicians.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will conduct as double-blind manner. At the beginning for each patient, a summary of pathophysiology and common treatment paths will be clarified. Then they will sign the informed consent to be treated in any of our groups by chance. The patients and their dermatologists who are present in all follow-up visits at the clinic and supervising the follow-up sessions and evaluating variables of treatment and other involved physicians in the clinic will be blinded. Only another non-involved researcher purchase the drugs from pharmaceutical companies and assigns them to group A and B and give them to the physician without interfering in the selection process or contacting the patients.
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
IsfahanUniversity of Medical Sciences,Hezarjirib street,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-10-29, 1399/08/08
Ethics committee reference number
IR.MUI.MED.REC.1399.661
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 Index
Timepoint
Measurement of Lichen planopilaris Activity Index at the beginning of the study (prior to treatment) and 2, 4, and 6 months after the treatment
Method of measurement
Using an oral questionnaire and clinical examination of patient for items in lichen planopilaris activity index
2
Description
Photography
Timepoint
Photography at the beginning of the study(prior to treatment) and 2,4 and 6 month after treatment.
Method of measurement
Professional camera for dermatologist
3
Description
Dermoscopy
Timepoint
Dermoscopy at the beginning of the study(prior to treatment) and 2,4 and 6 month after treatment.
Method of measurement
Handyscope fotofinder system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 16 patients, Methotrexate oral tablet (anti-neoplastic) made by Zahravi Pharmaceutical Co. 15 mg/week for 6 month.
Category
Treatment - Drugs
2
Description
Intervention group 2: 16 patients, Azathioprine oral tablet (2mg/kg/day) for 6 months from Ramopharmin Pharmaceutical Co.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Dissemination of data that has nothing to do with the personality and identity of the participants in the study and they are merely the consequences of study.
When the data will become available and for how long
Start the access period after the article is published.
To whom data/document is available
The data will only be available to approved academic researchers after their authentication by the relevant university.
Under which criteria data/document could be used
The data can only be used for research and writing review article.
From where data/document is obtainable
The author will be available via the email and university phone number mentioned in the article.
What processes are involved for a request to access data/document
Allows access to dataif found the data is requested for non-industrial and non-comercial use.