1. Comparison of mucosal adhesion of two forms of Clobetasol gel
2. Comparison of pain score, lesions size, and quality of life
3. Comparison of recovery time, according to Thongprasom index
Design
Patients will randomly divided into two groups with 22 individuals:
The first group will be prescribed mucoadhesive Clobetasol with formulation 1
The second group will be prescribed mucoadhesive Clobetasol with formulation 2
Settings and conduct
44 patients with oral lichen planus, referred to Isfahan Dental School, will be selected and will be divided into two groups with 22 individuals.
Patients will be treated with mucoadhesive Clobetasol for one month and oral lesions will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Diagnosis of oral lichen planus according to clinical criterias and histopathology
2. The age range: 16-70 years old
3. Non-use of local or systemic drugs to treatment of lichen planus (one week before start of the study)
4. Severity of lesions with 3, 4, and 5 scores according to Thongprasom index
5. Non-use of immunosuppressive drugs (one week before start of the study)
6. Non-use of drugs which cause lichenoid reaction (one week before start of the study)
Exclusion criteria:
1. Pregnancy and breastfeeding
2. Use of drugs which cause lichenoid reaction
3. Use of immunosuppressive drugs
4. Existence of any systemic disease other than lichen planus (example: viral, bacterial, and fungal infections; acute peptic ulcer; acute glomerulonephritis; myasthenia gravis)
5. Existence of lesions in direct contact with amalgam-treated teeth
6. Allergy to corticosteroids
Intervention groups
Two forms of mucoadhesive Clobetasol will be used to treatment of patients with lichen planus lesions
Main outcome variables
Pain score
Life quality index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200425047195N1
Registration date:2020-12-07, 1399/09/17
Registration timing:retrospective
Last update:2020-12-07, 1399/09/17
Update count:0
Registration date
2020-12-07, 1399/09/17
Registrant information
Name
Faezeh Khozeimeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3267 5638
Email address
khozeimeh.faezeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-26, 1399/07/05
Expected recruitment end date
2020-12-05, 1399/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Laboratory Indexes and Therapeutic Effects of Two Mucoadhesive Systems Containing Clobetasol on Oral Lichen Planus
Public title
Effects of two mucoadhesive forms of Clobetasol on oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of oral lichen planus according to clinical criterias and histopathology
The age range: 16-70 years old
Non-use of local or systemic drugs to treatment of lichen planus (one week before start of the study)
Severity of lesions with 3, 4, and 5 scores according to Thongprasom index
Non-use of immunosuppressive drugs (one week before start of the study)
Non-use of drugs which cause lichenoid reaction (one week before start of the study)
Exclusion criteria:
Pregnancy and breastfeeding
Use of drugs which cause lichenoid reaction
Use of immunosuppressive drugs
Existence of any systemic disease other than lichen planus (example: viral, bacterial, and fungal infections; acute peptic ulcer; acute glomerulonephritis; myasthenia gravis)
Existence of lesions in direct contact with amalgam-treated teeth
Allergy to corticosteroids
Age
From 16 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of quadruple blocks: size of the blocks is randomly selected. In each block, there is an equal number from each group. In quadruple blocks, two case groups and two control groups are considered
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, two mucoadhesive forms of Clobetasol will be compared. The drug forms are simulated and therefore participants of the study will have no information about the two drug forms.
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
Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-09-26, 1399/07/05
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.176
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
Pain intensity
Timepoint
Evaluation of pain intensity at start of the study, and at the first, second, third and fourth weeks after use of mucoadhesive Clobetasol
Method of measurement
Visual scale of pain
2
Description
Size of erosive and atrophic areas of oral lichen planus
Timepoint
Evaluation of pain intensity at start of the study, and at the first, second, third and fourth weeks after use of mucoadhesive Clobetasol
Method of measurement
Thongprasom index
Secondary outcomes
1
Description
Life quality
Timepoint
Evaluation of life quality at start of the study, and at the first, second, third and fourth weeks after use of mucoadhesive Clobetasol
Method of measurement
Questionnaire of chronic oral mucosal diseases
Intervention groups
1
Description
Intervention group: 1. Consumables specifications: mucoadhesive gel clobetasol RDN 0.05%. Chemical composition and concentration: each 100 mg contains 50 mg Clobetasol Propionate. Drug consumption time: rubbed on the region four times a day. Duration of drug use: one month.
Category
Treatment - Drugs
2
Description
Intervention group: 2. Consumables specifications: mucoadhesive Clobetasol Gel 0.05% made by Pharmaceutics. Chemical composition and concentration: each 100 mg contains 50 mg Clobetasol Propionate. Drug consumption time: rubbed on the region four times a day. Duration of drug use: one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Faezeh Khozeimeh
Street address
Department of Oral and Maxillofacial Diseases, School of Dentistry, Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5514
Email
Khozeimeh@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Faezeh Khozeimeh
Street address
Vice-President for Research, School of Dentistry, Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
dean@med.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
Faezeh Khozeimeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bagh Borj Complex, Bagh Borj Alley, Moshtaq St.
City
Isfahan
Province
Isfehan
Postal code
8158836341
Phone
+98 31 3267 5638
Email
Khozeimeh@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Faezeh Khozeimeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bagh Borj Complex, Bagh-e-Borj Alley, Moshtaq St.
City
Isfahan
Province
Isfehan
Postal code
8158836341
Phone
+98 31 3267 5638
Email
Khozeimeh@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Faezeh Khozeimeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bagh Borj Complex, Bagh Borj Alley, Moshtaq St.
City
Isfahan
Province
Isfehan
Postal code
8158836341
Phone
+98 31 3267 5638
Email
Khozeimeh@dnt.mui.ac.ir
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