Effect of immunotherapeutic G2 vaccine on Oral lichen planus(OLP)
The purpose of this study was to evaluate the efficacy of G2 vaccine on treatment of OLP pateints reffered to department of oral medecine ,faculty of dentistry, tehran university of medical sciences.
patients with atrophic-erosive lichen planus were included in this study.
Patients with systemic disease,pregnant and breast feeding women were excluded from the study.
Ten OLP patients (7 female, 3 male) were enrolled in this study. Diagnosis of OLP was on the basis of clinical criteria and histological study. Patients received subcutaneous injection of 0.4 cc of G2 vaccine, once a week for twelve weeks. Oral symptoms before and after treatment assessed by visual analogue scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810112950N1
Registration date:2010-04-14, 1389/01/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-14, 1389/01/25
Registrant information
Name
Sayed Javad Kia
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 0775
Email address
djavadkia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Medical Science University
Expected recruitment start date
2003-11-21, 1382/08/30
Expected recruitment end date
2004-07-20, 1383/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of immunothrapeutic g2 vaccine on treatment of oral lichen planus
Public title
The effect of immunothrapeutic g2 vaccine on treatment of oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:atrophic-erosive oral lichen planus
Exclution criteria:systemic disease-breast feeding and pregnant weman-use of corticosteroids in the last month
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
clinical trial before after
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Vice Chancelor for research
Street address
Valiasr Ave-Dameshgh St-no 23
City
Tehran
Postal code
14167
Approval date
empty
Ethics committee reference number
130/6052
Health conditions studied
1
Description of health condition studied
Oral Lichen Planus
ICD-10 code
L00-L99
ICD-10 code description
Other Lichen Planus
Primary outcomes
1
Description
Pain and burning sensation asking from pateints
Timepoint
Once a week for 12 weeks
Method of measurement
Visual analoge scle-0=no pain and burning and 10 the most pain and burning
2
Description
CD4 and CD8 count
Timepoint
before injections-end of injections(13th week)
Method of measurement
number of CD4 and CD8 in peripheral blood(by flowcytometry)
Secondary outcomes
1
Description
Treatment oral lichen planus lesions(reduce size of lesions)
Timepoint
Before injection-sixth week-twelveth week
Method of measurement
Ruler(mm2)
Intervention groups
1
Description
Immunotherapeutic G2 vaccine -Ampule 0.4 cc -sub cutaneous injection in deltoid region once a week for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral Medecine Department,School of Dentistry,Tehran University
Full name of responsible person
Dr Sayed Javad Kia
Street address
Enghelab Ave,Ghods Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dr Mohaghegh Biotechnology Reaserch Center
Full name of responsible person
Dr Saleh Mohaghegh Hazrati
Street address
Tehran-Mail box 13155-148
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr Mohaghegh Biotechnology Reaserch Center
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
Guilan Dental School
Full name of responsible person
Dr Sayed Javad Kia
Position
Assistant profesor
Other areas of specialty/work
Street address
Dental school-Emam khomeini Ave-Rasht-Guilan
City
Rasht
Postal code
Phone
+98 13 1323 0775
Fax
Email
Djavadkia@yahoo.com-Djavadkia@GUMS.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan Dental School
Full name of responsible person
Dr Sayed Javad Kia
Position
Assistant profesor
Other areas of specialty/work
Street address
Rasht-Emamam khomeini Ave
City
Rasht
Postal code
Phone
+98 13 1323 0775
Fax
Email
Djavadkia@yahoo.com-Djavadkia@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental School of Dentistry
Full name of responsible person
Dr Sayed Javad Kia
Position
Assistant profesor
Other areas of specialty/work
Street address
Rasht -Emam Khomeini Ave
City
Rasht
Postal code
Phone
+98 13 1323 0775
Fax
Email
Djavadkia@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)