]>
IRCT20230822059222N1 IRCT 2023-10-07 Shiraz University of Medical Sciences Topical steroid in Managing Skin Involvement of Patients with Idiopathic Granulomatous Mastitis. A Randomized Clinical Trial to Evaluate the Efficacy of Systemic Treatment in Combination with Topical steroid versus Systemic Treatment Alone in Managing Skin Involvement of Patients with Idiopathic Granulomatous Mastitis. 2023-10-22 anticipated 40 Complete https://irct.ir/trial/72922 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will employ stratified block randomization to ensure an even distribution of patients by disease grade. We will enroll 12 patients with grade 2, 16 patients with grade 3, and 12 patients with grade 4. Then, we will use a block randomization method with blocks containing 4 patients each to randomly assign patients to either the intervention or control group within each disease grade. 2 Idiopathic Granulomatous Mastitis. Intervention 1: Intervention group: The systemic treatment regimen will be adjusted based on the severity of the disease, as follows:- Grade II: Oral prednisolone with a starting dose of 30-20 mg/day, tapered over 6-8 weeks. In addition to prednisolone, 5 mg of oral methotrexate will be administered weekly.- Grade III: Oral prednisolone with a starting dose of 50-40 mg/day, tapered over 20-24 weeks. In addition to prednisolone, 15 mg of oral methotrexate will be administered weekly.- Grade IV: Oral prednisolone with a starting dose of 60-50 mg/day, tapered over 20-30 weeks. In addition to prednisolone, 15 mg of oral methotrexate will be administered weekly. For the first two weeks of treatment, a combination of antibiotics (ciprofloxacin 500 mg every 12 hours and metronidazole every 8 hours) will be used. All patients will receive daily administration of calcium-D and folic acid supplements to prevent osteoporosis and folate deficiency. Topical treatment: The topical treatment will consist of the application of Fluocinolone ointment twice a day for the first 5 days of the week and Mometasone ointment twice a day for two days of the weekend for 6 months. Intervention 2: Control group: The systemic treatment regimen will be adjusted based on the severity of the disease, as follows:- Grade II: Oral prednisolone with a starting dose of 30-20 mg/day, tapered over 6-8 weeks. In addition to prednisolone, 5 mg of oral methotrexate will be administered weekly.- Grade III: Oral prednisolone with a starting dose of 50-40 mg/day, tapered over 20-24 weeks. In addition to prednisolone, 15 mg of oral methotrexate will be administered weekly.- Grade IV: Oral prednisolone with a starting dose of 60-50 mg/day, tapered over 20-30 weeks. In addition to prednisolone, 15 mg of oral methotrexate will be administered weekly. For the first two weeks of treatment, a combination of antibiotics (ciprofloxacin 500 mg every 12 hours and metronidazole every 8 hours) will be used. All patients will receive daily administration of calcium-D and folic acid supplements to prevent osteoporosis and folate deficiency. Yes - There is a plan to make this available What will be shared: Information about the main outcome of the study will be shared while maintaining the confidentiality of patient information. When: Data will be available,3months after publication To whom: Researchers affiliated with academic institutions Conditions: The use of data from this study in the form of higher and more complete sample size studies is not prohibited Where to obtain: Breast Diseases Research Center, Shahid Motahhrai Clinic affiliated to shiraz university of medical sciences How to obtain: Referring to the Breast Diseases Research center and after applying the request, the request will be evaluated in the approved meetings. Comments:
public Vahid Zangouri
Shahid Motahari Clinic, Namazi Square, Karimkhan Zand Street
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3612 1000 zangouri@sums.ac.ir Shiraz University of Medical Sciences scientific Vahid Zangouri
Shahid Motahari Clinic, Namazi Square, Karimkhan Zand Street
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3612 1000 zangouri@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) A confirmed diagnosis of idiopathic granulomatous mastitis (IGM) based on histopathological examination The patients should require non-surgical treatment for their condition The severity of involvement should be grade II, III, or IV according to the modified classification of Yuan et al Absent of breast carcinoma or other malignancies or systemic diseases such as vasculitis, collagen vascular disease, or sarcoidosis Absent of a risk factor for steroid therapy, such as hypertension or diabetes mellitus 18 years 65 years Female Lack of consent to participate in the study The severity of the conflict is grade 1 N61 Inflammatory disorders of breast Treatment - Drugs Treatment - Drugs Intervention group: The systemic treatment regimen will be adjusted based on the severity of the disease, as follows:- Grade II: Oral prednisolone with a starting dose of 30-20 mg/day, tapered over 6-8 weeks. In addition to prednisolone, 5 mg of oral methotrexate will be administered weekly.- Grade III: Oral prednisolone with a starting dose of 50-40 mg/day, tapered over 20-24 weeks. In addition to prednisolone, 15 mg of oral methotrexate will be administered weekly.- Grade IV: Oral prednisolone with a starting dose of 60-50 mg/day, tapered over 20-30 weeks. In addition to prednisolone, 15 mg of oral methotrexate will be administered weekly. For the first two weeks of treatment, a combination of antibiotics (ciprofloxacin 500 mg every 12 hours and metronidazole every 8 hours) will be used. All patients will receive daily administration of calcium-D and folic acid supplements to prevent osteoporosis and folate deficiency. Topical treatment: The topical treatment will consist of the application of Fluocinolone ointment twice a day for the first 5 days of the week and Mometasone ointment twice a day for two days of the weekend for 6 months. Control group: The systemic treatment regimen will be adjusted based on the severity of the disease, as follows:- Grade II: Oral prednisolone with a starting dose of 30-20 mg/day, tapered over 6-8 weeks. In addition to prednisolone, 5 mg of oral methotrexate will be administered weekly.- Grade III: Oral prednisolone with a starting dose of 50-40 mg/day, tapered over 20-24 weeks. In addition to prednisolone, 15 mg of oral methotrexate will be administered weekly.- Grade IV: Oral prednisolone with a starting dose of 60-50 mg/day, tapered over 20-30 weeks. In addition to prednisolone, 15 mg of oral methotrexate will be administered weekly. For the first two weeks of treatment, a combination of antibiotics (ciprofloxacin 500 mg every 12 hours and metronidazole every 8 hours) will be used. All patients will receive daily administration of calcium-D and folic acid supplements to prevent osteoporosis and folate deficiency. 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, worsened, or relapsed that will be evaluated by 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, worsened, or relapsed that will be evaluated by surgeon. Resolution of skin involvement. Timepoint: One year after starting the treatment. Method of measurement: Assessed by the surgeon. Shiraz University of Medical Sciences Approved 2023-08-14 Ethics committee of Shiraz University of Medical Sciences Breast Disease Research Center, Shahid Motahari Clinic, Namazi Square, Karimkhan Zand Street Shiraz Fars Iran (Islamic Republic of)