This study is a randomized double-blind clinical trial aimed to compare the therapeutic effects of hydroxychloroquine with methotrexate in patients with localized scleroderma. A total of 30 patients with localized scleroderma will be randomized into two groups, after obtaining written consent to receive methotrexate 15 mg every Friday and folic acid daily except Fridays or hydroxychloroquine twice a day. For 12 weeks. The patients are clinically evaluated every 4 weeks in terms of the severity of localized scleroderma according to extent of involvement, thickness and flexibility at the start of the trial and weeks 4, 8 and 12 during the intervention, then every 4 weeks up to 3 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110057712N2
Registration date:2011-10-22, 1390/07/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-22, 1390/07/30
Registrant information
Name
Hamideh Azimi
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 41 1541 2120
Email address
azimih@tbzmed.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences and Health Services
Expected recruitment start date
2011-03-01, 1389/12/10
Expected recruitment end date
2011-07-01, 1390/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hydroxychloroquine with methotrexate in the treatment of patients with localized scleroderma
Public title
Comparison of hydroxychloroquine with methotrexate in the treatment of patients with localized scleroderma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of morphea without any signs of systemic involvement, evidence of active and expanding lesions (evidence of the spreading lesions, the appearance of new lesions or clinical signs of inflammation include erythema and warmth over the past 3 months), morphea confirmed with a histological samples from all patients before treatment, any systemic treatment with effect on morphea had to be discontinued for at least 4 weeks and topical treatments for at least 2 weeks prior to the study,
Exclusion criteria: Acute or chronic infection, pregnancy or childbearing potential without an acceptable method to prevent, Liver disease or elevated liver enzyme levels more than twice the normal, creatinine level of more than 130 mmol, known pulmonary disease, leukocyte count less than 3500 or platelet count less than 150000, active peptic ulcer or neoplasm, insulin-dependent diabetes mellitus, Use of other anti-folate drugs such as sulfonamides, and allopurinol and Probenesid, Presence of Lupus or Mixed connective tissue disease (MCTD), Contraindication of Ophthalmology to start hydroxychloroquine
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 and Health Services
Street address
Tabriz University of Medical Sciences, Daneshghah Avenue, Tabriz
City
Tabriz
Postal code
Approval date
2011-06-29, 1390/04/08
Ethics committee reference number
5/4/2799
Health conditions studied
1
Description of health condition studied
localized scleroderma
ICD-10 code
L94.0
ICD-10 code description
localized scleroderma(morpea)
Primary outcomes
1
Description
improvment of clinical lesion
Timepoint
every 4 weeks
Method of measurement
MSS
Secondary outcomes
1
Description
improvment of induration
Timepoint
every 4 week
Method of measurement
VAS(visual analoge scale)
2
Description
improvment of pruritus
Timepoint
every 4 weeks
Method of measurement
VAS(visual analoge scale)
Intervention groups
1
Description
Group A: oral methotrexate 15 mg Fridays and oral folic acid daily except Fridays for 12 weeks
Category
Treatment - Drugs
2
Description
Group B: oral hydroxychloroquine 200 mg twice a day, for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Dermatology- Sina Hospital- Tabriz
Full name of responsible person
Maryam Nasimi
Street address
Sina Hospital- Azadi Avenue-Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Dr Meshkini
Street address
Tabriz University of Medical Sciences and Health Services- Daneshghah Avenue- 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 and Health Services
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 and Health Services
Full name of responsible person
Maryam Nasimi
Position
Dermatology Resident
Other areas of specialty/work
Street address
Sina Hospital-Azadi Avenue- Tabriz
City
Tabriz
Postal code
Phone
+98 41 1337 5759
Fax
Email
nasimi.maryam@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Hamideh Azimi
Position
Assistant Professor
Other areas of specialty/work
Street address
Sina Hospital-Azadi Avenue-Tabriz
City
Tabriz
Postal code
Phone
+98 41 1541 2120
Fax
Email
azimih@tbzmed.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Maryam Nasimi
Position
Dermatology Resident
Other areas of specialty/work
Street address
Sina Hospital- Azadi Avenue-Tabriz
City
Tabriz
Postal code
Phone
+98 41 1337 5759
Fax
Email
nasimi.maryam@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)