localized scleroderma. localized scleroderma(morpea)
Conditions
Interventions
Intervention 1: Group A: oral methotrexate 15 mg Fridays and oral folic acid daily except Fridays for 12 weeks. Intervention 2: Group B: oral hydroxychloroquine 200 mg twice a day, for 12 weeks.
Treatment - Drugs
Group A: oral methotrexate 15 mg Fridays and oral folic acid daily except Fridays for 12 weeks
Group B: oral hydroxychloroquine 200 mg twice a day, for 12 weeks
Sponsors
Tabriz University of Medical Sciences and Health Services
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvment of clinical lesion. Timepoint: every 4 weeks. Method of measurement: MSS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvment of induration. Timepoint: every 4 week. Method of measurement: VAS(visual analoge scale).;Improvment of pruritus. Timepoint: every 4 weeks. Method of measurement: VAS(visual analoge scale). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Nasimi
Tabriz University of Medical Sciences and Health Services
Outcome results
None listed