Effectiveness of Local Injection (Bethametasone LA) combined with Systemic therapy (Methotraxate and Prednisolone)and Topical Steroids injection alone or Systemic therapy alone in the Treatment of Idiopathic Granulomatous Mastitis
Phase 2
Recruiting
- Conditions
- Idiopathic Granulomatous Mastitis.Inflammatory disorders of breast
- Registration Number
- IRCT20200608047694N1
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 90
Inclusion Criteria
Female patients with Idiopathic Granulomatosis Mastitis
Female patients aged 18-65
Female patients with Idiopathic Granulomatosis Mastitis which require non-surgical treatment
Exclusion Criteria
Female patients with Idiopathic Granulomatosis Mastitis who has abcess
Female patients with Idiopathic Granulomatosis Mastitis which require surgical intervention or has breast cancer or other malignancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The disappearance of inflammatory signs. Timepoint: All Patients will be followed weekly in first month and then monthly for 5 months for detect symptoms. Method of measurement: The clinical response is categorized into completely healed, inadequately healed, stable, worsened, or relapsed that will be evaluated by surgeon.;Closure of fistula orifices. Timepoint: All Patients will be followed weekly in the first month and then monthly for 5 months to detect symptoms. Method of measurement: The clinical response is categorized into completely healed, inadequately healed, stable, and worsened that will be evaluated by the surgeon.;Disappearance of skin erosion. Timepoint: All Patients will be followed weekly in the first month and then monthly for 5 months to detect symptoms. Method of measurement: The clinical response is categorized into completely healed, inadequately healed, stable, and worsened that will be evaluated by the surgeon.
- Secondary Outcome Measures
Name Time Method Granulomatous mastitis recurrence in the Ipsilateral breast. Timepoint: All Patients will be exam by surgeon and sonography will be done for all of them at the last month of follow up. Method of measurement: The occurrence of Granulomatosis Mastitis will be assessed by the surgeon and doing sonography.