Evaluation of the effect of Methylprednisolone lozenge to improve symptoms of patient with oral lichen planus: An experimental study and a double-blinded randomized clinical trial
Determining the clinical efficacy of methylprednisolone lozenges in the treatment of oral lichen planus
Design
In this study, in which a phase 3 clinical trial is performed on 40 patients, patients are randomly assigned to methylprednisolone and control groups (20 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 40 patients with oral lichen planus referred to dental clinics in Ahvaz 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-Willingness to participate in the study and complete the ethical consent form.
3- Women should not be pregnant or breastfeeding.
4- Patients There is no confirmed history of allergic reactions following oral administration of methylprednisolone.
Exclusion criteria :
1- Exacerbation of oral lichen planus lesions.
2- Do not use the drug for two consecutive days.
3- allergic reaction to methylprednisolone.
Intervention groups
In the present study, patients will be divided into two groups: Methylprednisolone lozenge group and standard treatment group.
Main outcome variables
The amount of pain and burning
Severity of redness and inflammation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220115053724N1
Registration date:2022-09-23, 1401/07/01
Registration timing:registered_while_recruiting
Last update:2022-09-23, 1401/07/01
Update count:0
Registration date
2022-09-23, 1401/07/01
Registrant information
Name
Mohammadreza Rashidi Nooshabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 5135
Email address
abd.rashidi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-10-12, 1401/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Methylprednisolone 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 Methylprednisolone lozenge in oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Willingness to participate in the study and complete the ethical consent form
Women should not be pregnant or lactating
Not using allopurinol
Not using viral vaccines during treatment
Patients do not have a confirmed history of allergic reactions following the oral intake of methylprednisolone
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:
Aggravation of oral lichen lesions
Unwillingness to cooperate during treatment
Not using medicine for two consecutive days
Emergence of allergic reaction to methylprednisolone
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
40
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 twice 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.
the drug and the placebo are completely similar in terms of shape, color, smell, and taste.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of JundiShapur Ahvaz University of Medical Sciences
Street address
Ahvaz, Golestan Boulevard, Farvardin St., Shahrivar St., between Bahman and Esfand. No. 147, Unit 5
City
Ahvaz
Province
Khouzestan
Postal code
6135953735
Approval date
2022-08-20, 1401/05/29
Ethics committee reference number
IR.AJUMS.REC.1401.202
Health conditions studied
1
Description of health condition studied
Oral lichen planus disease
ICD-10 code
L43.8
ICD-10 code description
Other 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
Scoring Severe pain and burning using VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: including 20 patients who are diagnosed with oral lichen planus patients is based on the examination of the patient by a dentist specializing in oral and dental diseases or a biopsy of the tissue of one or more ulcers in the mouth. Patients in the methylprednisolone group, on days 1 to 10, use a lozenge containing 2 mg of methylprednisolone orally twice a day. In this research, methylprednisolone lozenge is prepared using methylprednisolone powder purchased from Caspian Pharmaceutical Company, which has a license from the Food and Drug Organization of Iran, and its safety is checked using standard quantitative and qualitative methods and toxicology.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 20 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 twice 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
Dr. Mohammad Shouryabi Clinic
Full name of responsible person
Mohammad Shouryabi
Street address
Kianpars main street, between second and third west streets, Zarin building, fourth floor, unit 16
City
Ahvaz
Province
Khouzestan
Postal code
6135953735
Phone
+98 61 3338 4746
Email
dsshoriabii@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zaker Kish
Street address
Golestan St., Shahrivar St., Esfand St., Ahvaz University of Medical Sciences, Central Library of the Research Vice-Chancellor of the University
City
Ahvaz
Province
Khouzestan
Postal code
6136643595
Phone
+98 61 3338 4746
Email
drshoriabii@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Javad Kushki
Position
University student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Golestan St., Shahrivar St., between Bahman and Esfand, No. 147, Unit 5
City
Ahvaz
Province
Khouzestan
Postal code
6135953731
Phone
+98 21 6624 5047
Email
javaddorton@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi Nooshabadi
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Esfand, Golestan, west beach, faculty of pharmacy, Gundishapur medical cciences University,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135953731
Phone
+98 61 3311 5135
Fax
+98 61 3311 5135
Email
abd.rashidi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi Nooshabadi
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Esfand, Golestan, west beach, faculty of pharmacy, Gundishapur medical cciences University,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135953731
Phone
+98 61 3311 5135
Fax
+98 61 3311 5135
Email
abd.rashidi@yahoo.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