Pemphigus vulgaris is a chronic autoimmune mucocutaneous bullous disease that can cause death if left untreated. Systemic corticosteroid in combination with imunosuppressive are the mainstay of therapy, however it is unclear which adjuvant drugs is superior overall. Azathioprine is the most used drug in Shiraz dermatology center; unfortunately it has bone marrow suppression and carcinogenic properties. Tacrolimus has been used for pemphigus, successively, in one case reports and a study on mice. It has favorable side effects compared to azathioprine. 46 pemphigus patients will be divided into 2 groups. The control group will receive prednisolone and azathioprine, and the other 23 patients will receive prednisolone and tacrolimus for a minimum of 6 months. Pemphigus activity scores, the time that new bulla formation stopped, and the time corticosteroid is tapered, will be documented and analyzed in 2 groups. The side effects of medications will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012073010450N1
Registration date:2013-02-23, 1391/12/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-23, 1391/12/05
Registrant information
Name
Maryam Sadat Sadati
Name of organization / entity
Shiraz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 8419
Email address
sadatim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical sciences
Expected recruitment start date
2010-04-01, 1389/01/12
Expected recruitment end date
2012-03-31, 1391/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of efficacy of oral prednisolone plus tacrolimus and azathioprine in the treatment of pemphigus vulgaris patients
Public title
A comparison of efficacy of oral prednisolone plus tacrolimus and azathioprine in the treatment of pemphigus vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 46 patients from 20 to 80 years old; new pemphigus vulgaris or new disease activity; the clinical diagnosis of pemphigus vulgaris will be based on clinical presentation and histological analysis (+/- immunofluorescences study) of at least 1 biopsy specimen from the skin or the mucosa. Exclusion criteria: Having contraindications for the use of azathioprine, tacrolimus or prednisolone; any history of hypersensitivity to these drugs; active infection; pregnancy; lactation or no ability to attend follow-up; severe side effect during the study period.
Age
From 20 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
46
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
Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Postal code
Approval date
2012-04-05, 1391/01/17
Ethics committee reference number
cc-91-2849
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
arrest of disease progression
Timepoint
2 months
Method of measurement
arrest of new bulla fromation, 70% re-epithelization
Secondary outcomes
1
Description
remission of the disease
Timepoint
6-8 months
Method of measurement
no new bulla and no disease activity
Intervention groups
1
Description
Control group will receive azathioprine 2.5 mg/kg and prednisolone 1 mg/kg every day with gradual tapering of steroid during the follow up period.
Category
Treatment - Drugs
2
Description
Intervention group will receive tacrolimus 0.03 mg/ kg and prednisolone 1 mg/kg with gradual tapering of steroid during the follow up.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology ward and cutaneous leishmaniasis research center, Shiraz University of Medical Sciences
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mr. Eskandari
Street address
Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Sadati
Position
MD, dermatology resident
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Dermatology department, Zand street
City
Shiraz
Postal code
Phone
+98 71 1231 9049
Fax
Email
msadati63@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Dermatology ward
Full name of responsible person
Dr. Ladan Dastgheib
Position
MD
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Phone
+98 71 1231 9049
Fax
Email
dastghl@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)