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Evaluation of therapeutic effect of prednisolone + dapson with prednisolone+imurane in pemphigus vulgaris treatment

Protocol summary

Summary
The aim of this study is: Evaluation of therapeutic effect of prednisolone + dapson with prednisolone+imurane in pemphigus vulgaris treatment. This study is a randomized clinical trial. Population of patients with pemphigus vulgaris visit in, a dermatology clinic of Sina hospital or Sheikh Alrayys clinic, Tabriz, Iran. Inclusion criterion: patients with pemphigus vulgaris, that their disease was detected by the clinical or pathological evidence of initial tests with pemphigus vulgaris. Exclusion criterion: patients who were G6PDD. Thirty patients were selected and randomly divided into two groups; First group treatment with prednisolone + imurane and the second group treatment with prednisolone + dapson. The study has begun from 2011/12/22. The patients for eleven months and at weeks zero, one, two, three, and four, two months later, three months later, five months later, seven months later, nine months later and eleven months later of treatment, are evaluated for recovery and complications the patient has been taking a careful history and physical examination as well as the series of experiments, two groups were compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201307133566N2
Registration date: 2013-08-03, 1392/05/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-08-03, 1392/05/12
Registrant information
Name
Hamide Azimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
azimih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences
Expected recruitment start date
2012-09-19, 1391/06/29
Expected recruitment end date
2013-08-20, 1392/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of prednisolone + dapson with prednisolone+imurane in pemphigus vulgaris treatment
Public title
Effect of dapson in treatment of pemphigus vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: patients with pemphigus vulgaris, that their disease was detected by the clinical or pathological evidence of initial tests with pemphigus vulgaris. Exclusion criterion: patients who were G6PDD.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tabriz university of medical sciences
Street address
azady avenue,golgasht avenue
City
tabriz
Postal code
iran
Approval date
2012-09-15, 1391/06/25
Ethics committee reference number
9189

Health conditions studied

1

Description of health condition studied
Pemphigus vulgaris
ICD-10 code
L10.0
ICD-10 code description
Pemphigus vulgaris

Primary outcomes

1

Description
Severity of damage
Timepoint
The patients for eleven months and at weeks zero, one, two, three, and four, two months later, three months later, fiv months later e, seven months later, nine months later and eleven months later of treatment follow up
Method of measurement
Physical examination

Secondary outcomes

1

Description
Lipid profile
Timepoint
The patients for eleven months and at weeks zero, one, two, three, and four, two months later, three months later, fiv months later e, seven months later, nine months later and eleven months later of treatment follow up
Method of measurement
Lab tests

2

Description
HTN
Timepoint
the patients for eleven months and at weeks zero, one, two, three, and four, two months later, three months later, fiv months later e, seven months later, nine months later and eleven months later of treatment follow up
Method of measurement
lab

3

Description
Liver function test
Timepoint
The patients for eleven months and at weeks zero, one, two, three, and four, two months later, three months later, fiv months later e, seven months later, nine months later and eleven months later of treatment follow up
Method of measurement
Lab tests

Intervention groups

1

Description
control: treatment by prednisolone+imurane prednisolone 1-2mg/kg/day imurane:2-3mg/kg/day
Category
Treatment - Drugs

2

Description
Interventionaris treatment by prednisolone + dapson prednisolone 1-2mg/kg /day dapson100-200mg/day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology cilinic of Sina hospital
Full name of responsible person
Dr. Azimi Dermatologist
Street address
sina hospital Azadi Avenue
City
Tabriz

2

Recruitment center
Name of recruitment center
Sheikh Alrayys chinic
Full name of responsible person
Dr. Azimi dermatologist
Street address
Azadi avenue
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz university of medical sciences, assistance research
Full name of responsible person
Dr.meshkini
Street address
golgasht avenue, azady avenu tabriz
City
Tabriz
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, assistance research
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
Tabriz university of medical sciences
Full name of responsible person
Dr. Hamide Azimi
Position
Dermatologist
Other areas of specialty/work
Street address
Sina hospital, Azadi avenue
City
Tabriz
Postal code
5163639888
Phone
+98 41 1540 6612
Fax
+98 41 1540 6612
Email
azimi@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr. Hamide Azimi
Position
Dermatologist
Other areas of specialty/work
Street address
Sina hospital, Azadi avenue
City
Tabriz
Postal code
5163639888
Phone
+98 41 1540 6612
Fax
+98 41 1540 6612
Email
azimi@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact

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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