The aim of this study is to evaluate the effect and safety of topical insulin in the treatment of oral lichen planus.
Design
A double-blind clinical trial will be conducted as a control group (local normal saline) and an intervention group (local insulin) with 19 patients in each group.
The randomization method will be based on block randomization.
Settings and conduct
The location of this study is the dermatology department of Razi Dermatology Hospital in Tehran. This study will be conducted on 38 oral lichen planus patients in a double-blind, block-blinded design from 2025 to 2026.
Participants/Inclusion and exclusion criteria
Inclusion criteria :َ All Patients with a confirmed diagnosis of Oral Lichen Planus .
Exclusion criteria : Diabetic patients; Immunosuppressive patients; Pregnancy; Patients without systemic treatment
Intervention groups
Intervention group: 19 patients with oral lichen planus will be treated with topical insulin 1 unite per cc twice daily for three months.
Control group: 19 patients with oral lichen planus will receive topical normal saline twice daily as a placebo.
Main outcome variables
Change in size of the lesion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241208063991N1
Registration date:2025-05-16, 1404/02/26
Registration timing:registered_while_recruiting
Last update:2025-05-16, 1404/02/26
Update count:0
Registration date
2025-05-16, 1404/02/26
Registrant information
Name
Asheed Mohammed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 910 752 7437
Email address
asheed.almohammadi94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-19, 1404/01/30
Expected recruitment end date
2026-04-19, 1405/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of topical insulin in comparison of placebo in the treatment of patients with oral lichen planus
Public title
The effect of topical insulin on oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a confirmed diagnosis of Oral Lichen Planus
From any age group
Randomization: Random assignment of patients to local normal saline group (A) and local insulin group (B) will be done through block randomization as follows. In this way, each individual will be considered as a block. Binary blocks will be constructed in such a way that the AB combination (A means local normal saline, B means local insulin) will be given to the right of the individual and the local insulin to the left. Similarly, the BA combination will be given to the right of the individual and the local normal saline to the left. To prepare the random list, a random number table will be used in such a way that a random number will be selected at each stage. If the selected number will be between 0 and 4, the AB combination will be considered, and if the selected number will be between 5 and 9, the BA combination will be considered. In addition, in this study, blocks of 4, 6, and 8 will be used randomly to prepare the random list.
Blinding (investigator's opinion)
Single blinded
Blinding description
Both groups are given solutions without explanation of the type of solution, and the code is written as the letter A on the insulin solution and the letter B on the normal saline solution, which can be distinguished by the research team. Assignment to group A or B will be done based on a random table.
Placebo
Not used
Assignment
Parallel
Other design features
No
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of College of Medicine, Tehran University of Medical Science
Street address
Razi Hospital, Vahdat-e- eslami streat, Shapour square, Tehran
City
Tehran
Province
Tehran
Postal code
1416753955
Approval date
2024-11-13, 1403/08/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.379
Health conditions studied
1
Description of health condition studied
Oral Lichen planus
ICD-10 code
L43.9
ICD-10 code description
Lichen planus, unspecified
Primary outcomes
1
Description
The size of oral lichen planus lesions
Timepoint
Measurement of oral lichen planus lesion size will be performed at the beginning of the study (before the intervention begins) and 1, 2, and 3 months later
Method of measurement
The size of the waste will be measured with a ruler (unit: centimeters).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 19 patients receive topical insulin, 1 cc of regular topical insulin, 2 units per cc, twice daily for 3 months. Patients will be visited monthly and lesion size will be measured in square centimeters and photographs will be taken. Control group: 19 patients receive topical normal saline. In the second group, topical normal saline will be applied twice daily for 3 months. Patients will be visited monthly and lesion size will be measured in square centimeters and photographs will be taken.
Category
Treatment - Drugs
2
Description
Control group: 19 patients will receive topical normal saline. In this group, topical normal saline will be applied to the lesions twice a day, one cc, for three months. Patients will be visited every month and the size of the lesion will be measured in square centimeters and a photograph will be taken of the patient.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Dermatology Hospital
Full name of responsible person
Ashid Mohamed
Street address
Razi alley, Vahdat-e-eslami streat
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 910 752 7437
Email
asheed.almohammadi94@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ramin Kordi
Street address
Razi alley, Vahdat-e-eslami streat
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 910 752 7437
Email
nsm.maryam@gmail.com
Grant name
Tehran University of Medical Science
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ashid Mohamed
Position
Resident in dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 64, Khandan alley ,Vahdat-e-eslami street
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 910 752 7437
Email
asheed.almohammadi94@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Asheed Mohamed
Position
Resident in dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 64, Khandan alley ,Vahdat-e-eslami street
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 910 752 7437
Email
asheed.almohammadi94@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Asheed Mohamed
Position
Resident in Razi Dermatology Hospital
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 64, Khandan alley ,Vahdat-e-eslami street
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 910 752 7437
Email
asheed.almohammad94@gmail.com
Sharing plan
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
Data for all variables is provided upon request
When the data will become available and for how long
Data will be available all the time on request
To whom data/document is available
Data will be available for academic institution
Under which criteria data/document could be used
Data will be provided for other academic institution. Requests should be approved by Tehran University of Medical science
From where data/document is obtainable
Tehran University of Medical Science
What processes are involved for a request to access data/document
The process of obtaining data involve the research center in tehran university of medical science/ dermatology department.