Protocol summary

Summary
The main goal of this study is to determine locally effect of Cyclosporine and Dexametasone seprately and in combination with decreased dosage in oral lichen planuse management and evaluate the side effects. This study is randomized, double blind clinical trial and patients select according to inclusion and exclusion criteria Inclusion criteria ; Patients with oral lichen planus diagnosed according to modified WHO ; Painful lesion (VAS = 3-7 ) Exclusion criteria Patients with systemic disease :hypertension, pulmonary disease ,kidney disease , severe heart disease , chronic liver disease, uncontrolled diabetes ; pregnant or breast feeding patients and patients who take sterogene based drugs ; Patients who were under local or systemic agents for lichen planus with in two previous months ; Patients with history of cancer and using immunomodulating drugsin last two months ; oral lichen planuse concurrence with skin lesion or other mucosal lesion ; Patients who take beta blockers ,diuretics, anticonvulsants, barbiturates and ACE inhibitors ; Patient with complete denture. Sample size (36)consists of three groups of 12 patients ,Group 1: Dexamethasone 0.1%,Tid,5ml Group2: Cyclosporine 0.1%,Tid,5ml Group3: Dexamethasone 0.05 % + Cyclosporine 0.05 % ,Tid,5ml after oral examinations and recording clinical scoring and visual analogue scale they will be given mouth wash weekly for 6 weeks.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013100114713N1
Registration date: 2013-10-26, 1392/08/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-10-26, 1392/08/04
Registrant information
Name
Hamed Hossein kazemi
Name of organization / entity
Babol University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 1229 1408
Email address
h.kazemi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol university of medical sciences
Expected recruitment start date
2012-10-20, 1391/07/29
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Dexamethasone and Cyclosporine , seprarately and in combination in oral lichen planus
Public title
locallyl effect of Cyclosporin and Dexamethasone in oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria Patients with oral lichen planus diagnosed according to modified WHO criteria ; Painful lesions (VAS = 3-7 ) Exclusion criteria Patients with systemic disease :hypertension, pulmonary disease ,kidney transparent , heart disease , chronic liver disease, poor controlled diabetes ; pregnancy or breast feeding and patients who take sterogene based drugs ; Patients who were under local or systemic agents for lichen planus in last two months ; Patients with history of cancer and use immunomodulating drugs in last two months ; oral lichen planuse concurrence with skin lesion or other mucosal lesion ; Patients who take beta blockers ,diuretics, anticonvulsants, barbiturates and ACE inhibitors ; Patient with complete denture.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
N/A
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
Babol University of Medical Sciences
Street address
Babol,Ghanjafrooz avenue ,Babol university of medical science
City
Babol
Postal code
4717641367
Approval date
2013-05-12, 1392/02/22
Ethics committee reference number
2498

Health conditions studied

1

Description of health condition studied
oral lichenplanuse
ICD-10 code
L43
ICD-10 code description
lichen planus

Primary outcomes

1

Description
lesion size
Timepoint
befor intervation, weekly for 6 weeks
Method of measurement
Thongprasom scoring system

2

Description
pain
Timepoint
befor intervation, weekly for 6 weeks
Method of measurement
visual pain score

Secondary outcomes

1

Description
Candidiasis superimposition
Timepoint
weekly for 6 weeks
Method of measurement
culture

2

Description
Telangiectasia
Timepoint
weekly for 6 weeks
Method of measurement
clinical examination

3

Description
atrophy
Timepoint
weekly for 6 weeks
Method of measurement
clinical examination

4

Description
mucosal change
Timepoint
weekly for 6 weeks
Method of measurement
clinical examination

5

Description
taste change
Timepoint
weekly for 6 weeks
Method of measurement
questionnaire form

6

Description
burning sensation
Timepoint
weekly for 6 weeks
Method of measurement
questionnaire form

Intervention groups

1

Description
Group 1: Dexamethasone 0.1%,Tid,5ml,6weeks
Category
Treatment - Drugs

2

Description
Group2: Cyclosporine 0.1%,Tid,5ml,6weeks
Category
Treatment - Drugs

3

Description
Group3: Dexamethasone 0.05 % + Cyclosporine 0.05 % ,Tid,5ml,6weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Babol University of Medical Sciences
Full name of responsible person
fateme yarmand
Street address
Babol,Ghanjafrooz avenue ,Babol university of medical science
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
fateme yarmand
Street address
Babol,Ghanjafrooz avenue ,Babol university of medical science
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Science
Full name of responsible person
fateme yarmand
Position
residency student
Other areas of specialty/work
Street address
Babol,Ghanjafrooz avenue ,Babol university of medical science
City
Babol
Postal code
4717641367
Phone
+98 11 1229 1408
Fax
Email
fateme.yarmand@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Hamed Hossein kazemi
Position
MScD
Other areas of specialty/work
Street address
Babol,Ghanjafrooz avenue ,Babol university of medical science
City
babol
Postal code
4717641367
Phone
+98 11 1229 1408
Fax
Email
hamhk202@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Fateme Yarmand
Position
residency student
Other areas of specialty/work
Street address
Babol,Ghanjafrooz avenue ,Babol university of medical science
City
Babol
Postal code
4717641367
Phone
+98 11 1229 1408
Fax
Email
fateme.yarmand@gmail.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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