Comparative of Betamethasone pulse, Methotrexate pulse and Betamethasone Combination using Methotrexate pulse Therapy in Treatment of Severe Alopecia Areata
Comparison of betamethasone pulse, methotrexate pulse and pulse betamethasone combination with methotrexate in the treatment of severe alopecia areata.
Design
This clinical trial will be carried out in a double-blind randomized trial in Phase III studies consist of 36 patients in 3 groups .according to the random numbers table. the sample size was considered in each group of 12 patients Patients, the first group is treated with betamethasone pulse, the second group is treated with methotrexate pulse and the third group is treated with pulse methotrexate and betamethasone.
Settings and conduct
Patients referred to the Dermatology Clinic of Al Zahra Hospital and Sedigheh Tahereh, with the criteria for entering the study, are numbered and the numbers are randomly divided into three groups. In all three groups, the necessary tests will be performed prior to the start of the treatment, and During the study according to the protocol. After 6 months of treatment, patients were evaluated for the response rate and relapse for another three months by using photographic and VAS changes in patients' recovery. This is a double-blind clinical trial in which patients, researchers, evaluators, and analysts of any of the treatment groups will not be informed.
Participants/Inclusion and exclusion criteria
Patients with severe alopecia areata and resistant to treatment will be included in the study. If patients with the above conditions have contraindications for use of the drugs or Within a month prior to the study they had received systemic treatment Will not enter the study.
Intervention groups
The first group treated with betamethasone.
The second group receives methotrexate.
The third group receives methotrexate plus betamethasone.
Main outcome variables
Score of photographic scores; VAS score; percentage of the extent of the disease at the start of treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181226042136N1
Registration date:2019-01-15, 1397/10/25
Registration timing:retrospective
Last update:2019-01-15, 1397/10/25
Update count:0
Registration date
2019-01-15, 1397/10/25
Registrant information
Name
Zakiye Ganjei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2087
Email address
z.ganjei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
2017-07-23, 1396/05/01
Actual recruitment end date
2018-12-22, 1397/10/01
Trial completion date
2018-12-22, 1397/10/01
Scientific title
Comparative of Betamethasone pulse, Methotrexate pulse and Betamethasone Combination using Methotrexate pulse Therapy in Treatment of Severe Alopecia Areata
Public title
Comparison of Betamethasone and Methotrexate efficacy in the Treatment of Alopecia Areata
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The scalp involvement rate more than 50%
The disease is resistant to systemic and topical combination therapy
The patient is satisfied with the study
Exclusion criteria:
Pregnancy or Breastfeeding
Hb less than 9mg/dl
Leukocyte less than 4000
Platelet less than 100000
Potassium is less than 3.5
Liver enzymes 2 times more than the reference limit
ESR above reference limit
Positive Stool Test for Strongyloides stercoralis
Positive tests for viral hepatitis
Use of any systemic drug a month before the start of the study
There is a contraindication for betamethasone (diabetes, high blood pressure, drug allergy, active infection, recent surgery history, osteoporosis, stomach ulcer and psychosis, or depression)
Sensitivity to methotrexate
Age
From 16 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Actual sample size reached:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Patients whose entry criteria apply to them are numbered and the number of Habs based on the random numbers table is divided into three groups. Patients in the first group were treated with betamethasone pulse, the second group was treated with methotrexate pulse and the third group treated pulse combinations Methotrexate and Betamethasone
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, researchers and, evaluators will not be aware of the treatment groups, Medications are given to patients without a name and specification. Information will be provided to surveyors in the form of questionnaires delivered to the evaluators. The data is given for analysis as encoded and unnamed groups and profiles to the information analyzer.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Soffeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2017-06-22, 1396/04/01
Ethics committee reference number
IR.MUI.MED.REC.1397.146
Health conditions studied
1
Description of health condition studied
Alopecia Areata
ICD-10 code
L63
ICD-10 code description
Alopecia areata
Primary outcomes
1
Description
Photographic Scoring for patients with Alopecia Areata
Timepoint
Before the start of the study and 3 , 6, 9 months after the start of treatment
Method of measurement
Photographic Scoring
2
Description
Visual Analogue Scale Score in patient with Alopecia Areata
Timepoint
Before the start of the study and 3 , 6, 9 months after the start of treatment
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The first group will be treated with 3 mg betamethasone per oral in the form of 0.5 mg tablets (made by Iran Hormones Co.) and with a dose of 1 mg for breakfast, lunch, and dinner on a specified day, weekly, for 6 months.
Category
Treatment - Drugs
2
Description
Intervention group 2: The second group will be treated with 15 mg methotrexate per oral in the form of 2.5 mg tablets (Ebetrex made by Pfizer Co ) and with a dose of 5 mg for breakfast, lunch and dinner, on a specified day, weekly, for 6 months.
Category
Treatment - Drugs
3
Description
Intervention group 3: The third group will be treated with 15 mg methotrexate per oral in the form of 2.5 mg tablets (Ebetrex made by Pfizer Co ) and with a dose of 5 mg for breakfast, lunch and dinner on a specified day(Friday) plus 3 mg betamethasone PO in the form of 0.5 mg tablets (made by Iran Hormones Co.) and with a dose of 1 mg for breakfast, lunch and dinner, on another specified day(Saturday), weekly, for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Zakiye Ganjei
Street address
Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
alzahra@mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zakiye Ganjei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
z.ganjei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zakiye Ganjei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
z.ganjei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zakiye Ganjei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
z.ganjei@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
Yes - There is 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 primary outcome data will be shared
When the data will become available and for how long
Start the access period is 6 months after publishing the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
The request can be made by e-mail to the corresponding author
From where data/document is obtainable
It can be done by e-mail to z.ganjei@gmail.com
What processes are involved for a request to access data/document
Once the applicant has provided details of their ongoing project within one month from the time of application data will be available.