This clinical trial study will accomplish in Alzahra hospital of Isfahan in 2016.The target population are patients wit Plaque-type Psoriasis. The patients with inclusion criteria will be selected and randomly divided in to two groups, in the manner that first one was drawn into one of the groups and other patient will be alternatively placed in the other group until the required sample size was obtained.
In the first group 15 mg Methotrexate single dose weekly will be administrated for 12 weeks and in the second group, same amount of Methotrexate plus 3 mg Betamethasone will be administrated weekly for the same period. Patients will follow up during next 6 months after complete of treatment for detection of relapse and cure rate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010312782N9
Registration date:2016-05-22, 1395/03/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-22, 1395/03/02
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Methotrexate alone vs. Methotrexate plus Betamethasone in the Treatment of Plaque-type Psoriasis
Public title
Treatment of Plaque-type Psoriasis with Methotrexate plus Betamethasone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with Plaue type of Psoriasis with involvement above 10% of body; Age range15-65; No sensitivity to Methotrexate; No contraindication for Betamethasone use; No comorbidity with other Autoimmune diseases.
Exclusion criteria: Patients resume from participation in the study; Impossibility of follow up of the patient due to various reason; Use of other treatment method during the study; Receive of other drugs during the study; Occurrence of drugs adverse reactions.
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib Street, Isfahan, Iran
City
Isfahan
Postal code
1343478645
Approval date
2014-05-11, 1393/02/21
Ethics committee reference number
393179
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40.0
ICD-10 code description
Psoriasis Vulgaris
Primary outcomes
1
Description
Psoriasis Area Severity Index
Timepoint
Once any 2 Months
Method of measurement
Physical Examination
Secondary outcomes
empty
Intervention groups
1
Description
In Intervention group, 15 mg Methotrexate plus 3 mg Betamethasone administred weekly up to 12 weeks.
Category
Treatment - Drugs
2
Description
In Control group 15 mg Methotrexate administred weekly up to 12 weeks.