Evaluation of the effect of azathioprine lozenge to improve symptoms of patient with oral lichen planus: An experimental study and a double-blinded randomized clinical trial
Evaluation of the clinical efficacy of azathioprine in the treatment of oral lichen planus
Design
In this study, in which a phase 3 clinical trial is performed on 50 patients, patients are randomly assigned to azathioprine and control groups (25 patients in each group). How to place patients in these two groups is simple random and based on the RAND function of Excel software. This study is double-blind and the physician and patient do not know which group they belong to.
Settings and conduct
The study was performed on 50 patients with oral lichen planus referred to dental clinics in Yazd under the supervision of an oral pathologist. Medicines are prepared in uniform containers and patients receive one of the medicine containers based on random numbers. Neither the doctor nor the patient knows the contents of the medicine container.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Age 18 to 60 years 2- Women should not be pregnant or breastfeeding 3- Do not use allopurinol 5- Do not use viral vaccines during treatment 5- Patients There is no confirmed history of allergic reactions following oral administration of azathioprine.
Exclusion criteria: 1- Exacerbation of oral lichen planus lesions 2- Do not use the drug for two consecutive days 3- Allergic reaction to azathioprine
Intervention groups
In the present study, patients will be divided into two groups: azathioprine lozenge group and standard treatment group.
Main outcome variables
the pain; Inflammation; Burning; Intensity of redness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191106045356N10
Registration date:2021-12-21, 1400/09/30
Registration timing:prospective
Last update:2021-12-21, 1400/09/30
Update count:0
Registration date
2021-12-21, 1400/09/30
Registrant information
Name
Mohsen Zabihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3865
Email address
mzabihi100@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-05-14, 1401/02/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of azathioprine lozenge to improve symptoms of patient with oral lichen planus: An experimental study and a double-blinded randomized clinical trial
Public title
Evaluation of the clinical effect of azathioprine lozenge in oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women should not be pregnant or breastfeeding
Do not use allopurinol
Do not use viral vaccines during treatment
Patients do not have a confirmed history of allergic reactions following oral administration of azathioprine
The patient does not have a low level of consciousness
The patient should not be treated with warfarin
The patient does not have an active viral disease
Exclusion criteria:
Do not use the drug for two consecutive days
Exacerbation of oral lichen planus lesions
Allergic reaction to azathioprine
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
For blindness, different groups of drugs are placed in uniform and coded containers labeled A or B. In such a way that the physician and the patient do not know the type of medicine in each medicine container. Patients who meet the inclusion criteria receive one of the drugs labeled A or B by a simple randomization method based on the random number function (RAND), of Excel software.
Patients will take the drug three times a day and at the beginning of treatment and after every 2 days for up to 10 days, the status of oral lichen planus lesions will be evaluated.
Blinding (investigator's opinion)
Double blinded
Blinding description
Different groups of drugs are placed in uniform and coded containers, and the prescribing physician and the evaluator do not know the composition and content of each drug container.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2021-10-27, 1400/08/05
Ethics committee reference number
IR.SSU.MEDICINE.REC.1400.202
Health conditions studied
1
Description of health condition studied
oral lichen planus
ICD-10 code
L43
ICD-10 code description
Lichen planus
Primary outcomes
1
Description
Redness and inflammation
Timepoint
At the beginning of treatment and after every 2 to 10 days, the status of oral lichen planus lesions is evaluated for the severity of redness and inflammation (score 0 to 4).
Method of measurement
Scoring severe redness and inflammation using a Reeda questionnaire
2
Description
Severe pain and burning
Timepoint
At the beginning of treatment and after every 2 to 10 days, the condition of oral lichen planus lesions is evaluated for the severity of pain and burning (score 0 to 4).
Method of measurement
Severe pain and burning using VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Includes 25 patients who are diagnosed with oral lichen planus based on the patient's examination by a dentist or biopsy of the tissue of one or more ulcers in the mouth. Patients in the azathioprine group take lozenges containing 20 mg of azathioprine orally 3 times a day for days 1 to 10. Azathioprine lozenges in this study are prepared using azathioprine powder purchased from Ramofarmine Pharmaceutical Company, which has a license from the Food and Drug Administration of Iran, and its safety toxicity is evaluated using standard quantitative and qualitative methods. At the beginning of treatment and after every 2 to 10 days, the status of oral lichen planus lesions in terms of pain intensity and irritation (score 0 to 4), and severity of redness and inflammation (score 0 to 4), and the number of lesions were assessed through a questionnaire. Placed.
Category
Treatment - Drugs
2
Description
Control group: includes 25 patients who are diagnosed with oral lichen planus based on the patient's examination by a dentist or oral biopsy of one or more wounds in the mouth. Patients in the control group use topical corticosteroids such as triamcinolone acetonide 3 times a day for days 1 to 10, which is considered as the standard and accepted treatment for this disease according to reliable medical sources. At the beginning of treatment and after every 2 to 10 days, the status of oral lichen planus lesions in terms of pain intensity and irritation (score 0 to 4), and severity of redness and inflammation (score 0 to 4), and the number of lesions were assessed through a questionnaire.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental clinics
Full name of responsible person
Dr. Mohsen Zabihi
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Masood Mirzaei
Street address
Bahonar sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Email
mzabihi100@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Email
mzabihi100@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Email
mzabihi100@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available