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Effect of mucoadhesive form of mycophenolate mofetil on oral erosive lichen planus lesions

Protocol summary

Summary
Lichen planus (LP), a relatively common mucocutaneous disease. Activated T cells are important in the pathogenesis of LP as indicated by the dermal lymphocytic infiltrate leading to keratinocyte destruction and lesion formation. Mycophenolate mofetil (MMF), which specifically and reversibly inhibits the proliferation of activated T cells, was introduced in the treatment of autoimmune and inflammatory skin disorders. Furthermore, MMF has also been successfully used in the treatment of graft-versus-host disease (GVHD). Both GVHD and LP are characterized by activated T cells, which play a pivotal role in lesion formation. Thus, we have used MMF for the treatment of oral lichen planus (OLP). In this double blind trial, 27 patients, referring to Oral Medicine Department of Tabriz Dental School were recruited.10 patients have bilateral ulcerative lesions of OLP and they will be enrolled in a double blind clinical trial study (group A). 17 patients which have unilateral ulcerative lesion of OLP, will be enrolled in a before-after clinical trial study (group B).The lesion size with digital culis and pain quantity with Visual Analogue Scaling (VAS) will be recorded before and after treatment. In group A, patients will be instructed to put 2% MMF mucoadhesive on one of the dried lesions and put the placebo on the other one, twice daily for 4 weeks. In group B, patients will use only 2% MMF mucoadhesive in the same manner. Results will be analyzed by McNemar's test and wilcoxon test by using of spss software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013011611976N2
Registration date: 2013-05-23, 1392/03/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-23, 1392/03/02
Registrant information
Name
Ali Taghavi Zenuz
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
taghavia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Tabriz University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-06-20, 1392/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Effect of mucoadhesive form of mycophenolate mofetil on oral erosive lichen planus lesions
Public title
Effect of mycophenolate mofetil on oral erosive lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with erosive oral lichen planus with clinical manifestations and histopathological criteria; existence of two lesions with similar clinical appearance on the right and left buccal mucosa; patients older than 18 years of age. Exclusion criteria: not received any treatment for the lesions for at least 4 weeks ago; any factor that cause lichenoid reaction; any systemic or dermal disease which affects immune system of the patient; incidence of any adverse effect of mycophenolate mofetil during the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 27
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Deputy of tabriz university of medical sciences
Street address
Tabriz-Golgasht street-university of medical sciences -central building no 2-3th floor
City
tabriz
Postal code
5166614713
Approval date
2013-05-04, 1392/02/14
Ethics committee reference number
9210

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
Size of lesion
Timepoint
Baseline and after 1 month
Method of measurement
Measured by digital culis

2

Description
Pain and burning sensation
Timepoint
Baseline and weekly for one month
Method of measurement
The oral lesions will be clinically graded based on VAS grading scale

Secondary outcomes

1

Description
Adverse effects
Timepoint
Evrey week for 1 month
Method of measurement
Clinical examination

Intervention groups

1

Description
Intervention side: mucoadhesive of mycophenolate mofetil 2%,for 1month, twice daily, after breakfast at 10 & in the afternoon at 5.
Category
Treatment - Drugs

2

Description
Control side: orabase, for 1month,twice daily, after breakfast at 10 & in the afternoon at 5.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Oral Medicine Department- Dental Faculty-Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Taghavi Zenuz
Street address
Tabriz- Golgasht sreet- Dental School- Oral Medicine Department
City
tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr Seied Kazem Shakori
Street address
Tabriz- Golgasht street- Tabriz University of Medical Sciences- Central building no 2- 3th floor
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Negin Samiei
Position
Dentistry student
Other areas of specialty/work
Street address
Tabriz- Golgasht street- Faculty of Dentistry- Oral Medicine Department
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
n.samiei@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Taghavi Zonuz
Position
Associated professor of oral medicine
Other areas of specialty/work
Street address
Tabriz- Golgasht street- Faculty of Dentistry- Oral Medicine Department
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
taghavia@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Negin Samiei
Position
Dentistry Student
Other areas of specialty/work
Street address
Tabriz- Golgasht street- Dental Faculty- Oral Medicine Department
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
n.samiei@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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