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Evaluation of effectiveness of lycopen in improvement of erosive and atrophic oral lichen planus lesions

Protocol summary

Summary
Current randomized, double blind clinical trial is planned to evaluate effect of lycopene in treating erosive and atrophic forms of oral lichen planus lesions. 20 patients with oral lichen planus will be chosen out of all patients consulting zahedan dentistry collage their OLP lesions will be confirmed by histopathology. Age, medical history, sign and symptoms, duration, type, size and location of the lesions, in addition to any former history of skin lesions will be carefully written in informational forms. Diagnostic criteria is clinical and histopathological view of the lesions. Study subjects will be divided into 2 groups using quadruple blocks. In groupA, patients with olp will be examined and will receive topical corticosteroid in addition to lycopene patient will use the drug 4 times a day for 2 weeks (An hour befor each meal and 20 minutes befor sleep), and avoid eating, drinking and smoking for at least an hour after using the drug. One lycopene tab should be taken each day. In group B, patient will receive just topical corticosteroide. Both groups should be followed second week after starting the treatment. Follow up sessions will continue each week for 12 weeks. In each follow up session, size of thelesions will be measured by caliper.

General information

Acronym
OLP-oral lichen planus
IRCT registration information
IRCT registration number: IRCT201601113133N8
Registration date: 2016-04-18, 1395/01/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-18, 1395/01/30
Registrant information
Name
Fateme Arbabi Kalati
Name of organization / entity
Dental school of Zahedan
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 1814
Email address
farbabi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Zahedan University of Medical Sciences
Expected recruitment start date
2015-12-11, 1394/09/20
Expected recruitment end date
2016-12-10, 1395/09/20
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Evaluation of effectiveness of lycopen in improvement of erosive and atrophic oral lichen planus lesions
Public title
The effect of lycopene in the treatment of oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Diagnostic criteria is clinical and histopathological view of the lesions. Exclusion criteria: patients with systemic disease, skin lichen planus, drug user, pregnant wemen, smokers, patients with dysplastic lesions and lesions close to restorations and also patients receiving treatment for oral lesions was than a month ago.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 2
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Study subjects will be divided into 2 groups using quadruple blocks.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences-Dental school of Zahedan
City
Zahedan
Postal code
Approval date
2015-06-27, 1394/04/06
Ethics committee reference number
IR.ZAUMS.7256

Health conditions studied

1

Description of health condition studied
oral lichen planus
ICD-10 code
L43.8
ICD-10 code description
Other lichen planus

Primary outcomes

1

Description
Reduction in size of the lesion
Timepoint
Before starting treatment, every week for 12 weeks after starting treatment
Method of measurement
In each follow up session size of the lesion will be measured by caliper.

Secondary outcomes

1

Description
Reduced pain of the lesion
Timepoint
Before starting treatment, every week for 12 weeks after starting treatment
Method of measurement
Use of Visual Analoge Scale (VAS) from 0- 10, 0: no pain sensation and 10: severe pain sensation

Intervention groups

1

Description
Intervention group: In this group, patients will receive topical corticosteroid in addition to lycopene, patient will use the drug 4 times a day for 2 weeks (An hour befor each meal and 20 minutes befor sleep), and avoid eating, drinking and smoking for at least an hour after using the drug. One lycopene tab should be taken each day.
Category
Treatment - Drugs

2

Description
control group:In this group, patient will receive just topical corticosteroide and patient will to use the drug 4 times a day for 2 weeks (An hour befor each meal and 20 minutes befor sleep), and avoid eating, drinking and smoking for at least an hour after using the drug.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental school of Zahedan
Full name of responsible person
Dr.Fateme Arbabi Kalati
Street address
Zahedan, eastern Azadagan street, dentistry college
City
zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Zahedan University of Medical Sciences
Full name of responsible person
Dr.Fateme Arbabi Kalati
Street address
Dental school of Zahedan
City
zahedan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
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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
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Fateme Arbabi Kalati
Position
associated professor
Other areas of specialty/work
Street address
Zahedan, eastern Azadagan street, dentistry college
City
zahedan
Postal code
Phone
+98 54 1244 1824
Fax
Email
F kalati@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Arbabi-Kalti
Position
Assistant Professer of Oral medicine
Other areas of specialty/work
Street address
Dental school of Zahedan
City
zahedan
Postal code
Phone
+98 54 1244 1824
Fax
Email
F kalati@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Fateme Arbabi Kalati
Position
Associate Professor
Other areas of specialty/work
Street address
Zahedan, eastern Azadagan street, dentistry college
City
zahedan
Postal code
Phone
+98 54 1244 1824
Fax
Email
farbabi@razi.tums.ac.ir
Web page address

Sharing plan

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