Comparing the success rate of systemic administration and intralesional injection of rituximab in patients with pemphigus vulgaris with oral lesions.
Design
A parallel-group, unblinded, randomized, phase 2 clinical trial of 20 patients. A table of random numbers is used for randomization.
Settings and conduct
This study is conducted on 20 patients over 18 years old with pemphigus vulgaris with oral lesions in Tabriz Sinai Hospital. Subjects will be randomly assigned 10 people to the systemic administration group and 10 people to the systemic administration group with intralesional administration (10 mg/ml in two doses with an interval of 15 days). The variables studied before the study, day 15th, 33 months after injection will be checked and recorded. A complete response to treatment is considered a condition when the pemphigus vulgaris lesion severity score for mucosal lesions reaches zero. Patient satisfaction are also assessed with a visual analog scale.
Participants/Inclusion and exclusion criteria
Its target population is 20 patients over 18 years of age with pemphigus vulgaris with oral lesions who did not respond to corticosteroids and rituximab was started for them. Pregnant and lactating people, allergic to rituximab, coagulation, cardiovascular diseases, malignancy and hepatitis are excluded from the study.
Intervention groups
Systemic administration intervention where a 50 cc vial of rituximab containing 500 mg/50 ml is injected intravenously to patients four times with an interval of one week in a period of one month.
Intervention of intralesional injection of Rituximab with a dose of 10 mg/ml into the lesion twice with an interval of 15 days.
Main outcome variables
severity of pemphigus vulgaris lesion; Patient satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240604062002N1
Registration date:2024-07-11, 1403/04/21
Registration timing:prospective
Last update:2024-07-11, 1403/04/21
Update count:0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Faegheh Sheikhalizadeh Noubar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5921
Email address
sheikhalizadehf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
systemic administration and intralesional injection of rituximab in patients with pemphigus vulgaris with oral lesions
Public title
effects of rituximab in patients with pemphigus vulgaris with oral lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over 18 years old with pemphigus vulgaris with oral lesions
Patients who have not had a therapeutic response to corticosteroid administration
Patients for whom rituximab has been started
Exclusion criteria:
Pregnancy and breastfeeding
People who have coagulation problems
Patients with infection at the site of the lesion
Rituximab contraindications include hypersensitivity to it or its components
Having hepatitis B
Having cardiovascular diseases
Having malignant diseases
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization will be carried out on an individual basis by RandList software. The selection of patients will be based on sealed envelopes that be written A and B inside them. 20 envelopes will be prepared in two groups. After entering the clinic and before the visit, patients will receive the envelope from the secretary and hand it over to the physician.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Third floor, Central Building No.2, Tabriz University of Medical Sciences, Gholgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Approval date
2024-06-24, 1403/04/04
Ethics committee reference number
IR.TBZMED.REC.1403.254
Health conditions studied
1
Description of health condition studied
Pemphigus vulgaris lesion
ICD-10 code
L10.0
ICD-10 code description
Pemphigus vulgaris
Primary outcomes
1
Description
Severity of pemphigus vulgaris lesion
Timepoint
Before the study, on the 15th day, 33 months after the injection
Method of measurement
PVLSS: Pemphigus Vulgaris Lesion Severity Score
2
Description
Patient satisfaction
Timepoint
Before the study, on the 15th day, 33 months after the injection
Method of measurement
VAS: Visual analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First intervention: Systemic administration intervention where a 50 cc vial of rituximab containing 500 mg/50 ml is injected intravenously to patients four times with an interval of one week in a period of one month.
Category
Treatment - Drugs
2
Description
Intervention group: Second intervention: Systemic administration along with intralesional administration of 10 mg/ml on two occasions with an interval of 15 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Department of Sina Hospital, Tabriz University of Medical Sciences.
Full name of responsible person
Dr. Fayegh Sheikh Alizade Nobar
Street address
Sina Hospital, Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
faeghehsheikhalizadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Vice Chancellor for Research, Central Building of Tabriz University of Medical Sciences, Daneshgah Square
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Faegheh Sheikhalizadeh Nobar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 1540 6612
Email
faeghehsheikhalizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Faegheh Sheikhalizadeh Nobar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 1540 6612
Email
faeghehsheikhalizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Faegheh Sheikhalizadeh Nobar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 1540 6612
Email
faeghehsheikhalizadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The study data are classified and coded so that the names of the individuals cannot be identified. Access to all the study data will be possible except for the identifying information of the individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal
To whom data/document is available
Anyone interested in using the data can access the study data
Under which criteria data/document could be used
Study data can be used for comparison with other results
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The request will be sent by email to person responsible for scientific or public inquiries.