Localized scleroderma. Localized scleroderma [morphea]
Conditions
Interventions
Intervention 1: Intervention group: Pirfenidone ointment 10% manufactured by Isfahan University of Medical Science, School of Pharmacy, three times a day, for 8 weeks. Intervention 2: Control group: P
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Localized scleroderma diagnosed by a rheumatologist based on clinical manifestations and, if necessary, biopsy and histopathology. Age over 18 years
Exclusion criteria
Exclusion criteria: Incidence of other autoimmune diseases Receiving systemic anti-scleroderma medication within the past week Receiving topical immunosuppressive medication within the last two weeks Incidence of other chronic skin diseases (such as psoriasis, pemphigus, eczema, various types of dermatitis, and lichen planus) Incidence of skin infection at the site of the lesions Pregnancy Breastfeeding Sensitivity to the product under study (To determine possible sensitivity, a sensitivity test will be performed on all patients enrolled in the study. In this test, a small amount of ointment is applied to the back of the volunteers' arms and covered with an anti-allergic patch. On the inner surface of the other arm, only the adhesive is placed. The adhesive is removed after 24 hours and the results are reviewed half an hour later. In this test, redness and swelling of more than 0.5 mm is considered a positive reaction or sensitivity and the patient is excluded from the study.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Modified Localized Scleroderma Severity Index score in each patient before and after the end of the interventions. Timepoint: Before intervention - 8 weeks after the start of the intervention. Method of measurement: In 14 anatomical regions, the sum of the scores of the three parameters erythema, skin thickness, and lesion extension/new lesion will determine the score of the corresponding anatomical region and the sum of the scores of all regions will determine the total score, which ranges from 0 to 168. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in physician global assessment scores(PGA) and patient global assessment scores(PtGA) using the visual analog scale (VAS) before and after the intervention. Timepoint: Before intervention - 8 weeks after the start of the intervention. Method of measurement: The Physician Global Assessment (PGA) score will be recorded by the project rheumatologist and the Patient Global Assessment (PGA) score will be recorded by the patient based on symptoms over the past month using a visual analogue scale (VAS) with a score ranging from zero (no symptoms) to 10 (most severe symptoms). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRasool Soltani
Esfahan University of Medical Sciences
Outcome results
None listed