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IRCT20260509069303N1 IRCT 2026-06-14 Kashan University of Medical Sciences Systemic and local steroid injections in granulomatous mastitis. Local steroid injection versus systemic steroid therapy in the inflammatory phase of idiopathic granulomatous mastitis: a clinical trial randomized controlled study 2026-07-01 anticipated 60 Recruiting https://irct.ir/trial/90335 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the unit of randomization is each eligible patient. After assessment of the inclusion and exclusion criteria and obtaining written informed consent, patients will be randomly allocated in a 1:1 ratio to either the systemic treatment group receiving oral prednisolone or the local injection group receiving intralesional triamcinolone. Block randomization with a block size of 4 will be used. The random allocation sequence will be generated by an independent person who is not involved in patient treatment, using statistical software or a random number table. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. The envelope for each patient will be opened only after final enrollment and recording of baseline data. Stratified randomization will not be used in this study, Blinding description: Due to the obvious difference between the treatment methods, including oral prednisolone and intralesional triamcinolone injection, blinding of participants, clinical caregivers, the radiologist performing the injection, and the principal investigator is not feasible. Therefore, this study will be conducted as an open label randomized controlled clinical trial. Outcomes will be assessed based on clinical evaluation, ultrasonographic findings, and recording of predefined objective adverse events. To reduce bias, data will be recorded in a standardized checklist and, if feasible, statistical analysis will be performed using coded study groups so that the data analyst remains unaware of the allocated intervention. 1 idiopathic granulomatous mastitis. Intervention 1: Intervention group: Patients in this group will receive intralesional triamcinolone injection according to the extent and depth of the breast lesion. After local anesthesia, 40 mg of triamcinolone will be injected for each lesion and each involved layer, including superficial, intermediate, and deep layers. The maximum total dose of triamcinolone in each injection session will be 200 mg. The injection will be performed by an experienced radiologist under ultrasonographic guidance. To prevent gastrointestinal adverse effects, patients will receive 40 mg of oral pantoprazole daily. Intervention 2: Intervention group: Patients in this group will receive 20 mg of oral prednisolone daily, administered in two divided doses. Treatment will be continued according to the study protocol and the patient’s clinical response until the end of the three month follow up period. To prevent gastrointestinal adverse effects, patients will receive 40 mg of oral pantoprazole daily. Patients will be followed for treatment response and adverse effects at the end of the first, second, and third months. Yes - There is a plan to make this available What will be shared: All data will be shareable after individuals are de-identified. When: 6 months after publication of the article To whom: De identified individual participant data and study documents will be considered for access only after a written request from researchers affiliated with universities, research centers, or scientific institutions. Access to the data by commercial or industrial individuals or companies is not planned. Conditions: The data and documents may be used only for scientific and research purposes related to the study topic, secondary analyses, systematic reviews, meta analyses, or planning future studies. Submission of a research proposal, approval by the study team, protection of confidentiality, no attempt to identify participants, and commitment to use the data only for the approved purpose are required. Any publication based on the data must acknowledge the source study and comply with research ethics principles. Where to obtain: Requests for access to data or documents should be submitted in writing to the principal investigator or study investigator. The applicant should provide name and institutional affiliation, purpose of the request, type of required data or documents, and the proposed analysis plan. Contact information: Principal investigator Zahra Afshari, email address: Z-afshari@kaums.ac.ir How to obtain: After receiving a written request, the request will be reviewed regarding the research purpose, scientific affiliation of the applicant, type of requested data or documents, and compliance with ethical considerations. If necessary, additional information or a confidentiality agreement will be requested from the applicant. After approval by the study team, de identified individual participant data or available documents will be provided to the applicant. The result of the review will usually be communicated to the applicant within a maximum of 30 working days. Comments:
public Zahra Afshari
Pezeshk Blvd. - Qotb Blvd.
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5558 9905 Afshari-Z@kaums.ac.ir Kashan University of Medical Sciences scientific Zahra Afshari
Pezeshk Blvd. - Qotb Blvd.
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5558 9905 Afshari-Z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Women with idiopathic granulomatous mastitis confirmed by pathological diagnosismastitis Patients classified as group 2 according to the Turkish clinical classification including uncomplicated granulomatous Negative PCR test for tuberculosis Willingness to participate in the study and signing the written informed consent form Ability to attend the scheduled follow up visits 18 years no limit Female Presence of complicated granulomatous mastitis including abscess fistula or skin ulcer at the time of enrollment Evidence of breast malignancy or other known causes of granulomatous mastitis Definite contraindication to corticosteroid therapy Recent use of systemic corticosteroids or immunosuppressive drugs for the same disease Uncontrolled diabetes uncontrolled hypertension or severe active infection Pregnancy or lactation at the time of enrollment L92.8 Other granulomatous disorders of the skin and subcutaneous tissue Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group will receive intralesional triamcinolone injection according to the extent and depth of the breast lesion. After local anesthesia, 40 mg of triamcinolone will be injected for each lesion and each involved layer, including superficial, intermediate, and deep layers. The maximum total dose of triamcinolone in each injection session will be 200 mg. The injection will be performed by an experienced radiologist under ultrasonographic guidance. To prevent gastrointestinal adverse effects, patients will receive 40 mg of oral pantoprazole daily. Intervention group: Patients in this group will receive 20 mg of oral prednisolone daily, administered in two divided doses. Treatment will be continued according to the study protocol and the patient’s clinical response until the end of the three month follow up period. To prevent gastrointestinal adverse effects, patients will receive 40 mg of oral pantoprazole daily. Patients will be followed for treatment response and adverse effects at the end of the first, second, and third months. Treatment response at the end of the third month is defined as at least 50 percent reduction in the size of the breast lesion on ultrasonography accompanied by improvement or resolution of clinical signs of breast inflammation compared with baseline. Timepoint: At baseline before starting the intervention and at the end of the third month after starting the intervention. Method of measurement: The outcome will be measured using clinical breast examination and breast ultrasonography. In the clinical examination, pain, redness, swelling, mass, abscess, or fistula will be assessed, and on ultrasonography, the size of the breast lesion will be compared with baseline. Kashan University of Medical Sciences Approved 2026-04-19 Research ethics committee of faculty of medicine and faculty of dentistry - Kashan university of med Pezeshk Blvd. - Qotb Blvd. Kashan Isfehan Iran (Islamic Republic of)