drugset / Trial / NCT06985537
Steroid Injection in Idiopathic Granulomatous Mastitis
NaSingle-groupOpen-labelTreatment
Summary
Granulomatous mastitis (GM) is a non-infectious inflammatory breast condition typically affecting young women, often following breastfeeding. Management of GM often begins with anti-inflammatory medications and antibiotics. Steroids, particularly intralesional corticosteroids, are considered the first-line treatment for GM due to their rapid anti-inflammatory and immunosuppressive effects. Steroids help control symptoms such as painful lumps, swelling, and redness. Steroids' effectiveness in providing symptom relief minimizes the need for more invasive treatments such as surgery.
Timeline
- Start
- 2025-06
- Primary completion
- 2026-01
- Completion
- 2026-02
Publications
- Background Han BK, Choe YH, Park JM, Moon WK, Ko YH, Yang JH, Nam SJ. Granulomatous mastitis: mammographic and sonographic appearances. AJR Am J Roentgenol. 1999 Aug;173(2):317-20. doi: 10.2214/ajr.173.2.10430126.
- Background Toktas O, Konca C, Trabulus DC, Soyder A, Koksal H, Karanlik H, Kamali Polat A, Ozbas S, Yormaz S, Isik A, Sezgin E, Soran A. A Novel First-Line Treatment Alternative for Noncomplicated Idiopathic Granulomatous Mastitis: Combined Intralesional Steroid Injection with Topical Steroid Administration. Breast Care (Basel). 2021 Apr;16(2):181-187. doi: 10.1159/000507951. Epub 2020 Jun 30.
- Background Godazandeh G, Shojaee L, Alizadeh-Navaei R, Hessami A. Corticosteroids in idiopathic granulomatous mastitis: a systematic review and meta-analysis. Surg Today. 2021 Dec;51(12):1897-1905. doi: 10.1007/s00595-021-02234-4. Epub 2021 Feb 15.
- Background Erturk TF, Cakir O, Yaprak Bayrak B, Gunes A, Aydemir S, Utkan NZ. Local Steroid Treatment: An Effective Procedure for Idiopathic Granulomatous Mastitis, Including Complicated Cases. J Invest Surg. 2022 Apr;35(4):745-751. doi: 10.1080/08941939.2021.1933272. Epub 2021 Jun 21.
- Background Tekgoz E, Colak S, Cinar M, Yilmaz S. Treatment of idiopathic granulomatous mastitis and factors related with disease recurrence. Turk J Med Sci. 2020 Aug 26;50(5):1380-1386. doi: 10.3906/sag-2003-93.
- Background Skandarajah A, Marley L. Idiopathic granulomatous mastitis: a medical or surgical disease of the breast? ANZ J Surg. 2015 Dec;85(12):979-82. doi: 10.1111/ans.12929. Epub 2014 Nov 26.
- Background Mizrakli T, Velidedeoglu M, Yemisen M, Mete B, Kilic F, Yilmaz H, Ozturk T, Ozaras R, Aydogan F, Perek A. Corticosteroid treatment in the management of idiopathic granulomatous mastitis to avoid unnecessary surgery. Surg Today. 2015 Apr;45(4):457-65. doi: 10.1007/s00595-014-0966-5. Epub 2014 Jul 4.
- Background Akcan A, Oz AB, Dogan S, Akgun H, Akyuz M, Ok E, Gok M, Talih T. Idiopathic Granulomatous Mastitis: Comparison of Wide Local Excision with or without Corticosteroid Therapy. Breast Care (Basel). 2014 May;9(2):111-5. doi: 10.1159/000360926.
- Background Altintoprak F, Kivilcim T, Yalkin O, Uzunoglu Y, Kahyaoglu Z, Dilek ON. Topical Steroids Are Effective in the Treatment of Idiopathic Granulomatous Mastitis. World J Surg. 2015 Nov;39(11):2718-23. doi: 10.1007/s00268-015-3147-9.
- Background Chirappapha P, Thaweepworadej P, Supsamutchai C, Biadul N, Lertsithichai P. Idiopathic granulomatous mastitis: A retrospective cohort study between 44 patients with different treatment modalities. Ann Med Surg (Lond). 2018 Nov 9;36:162-167. doi: 10.1016/j.amsu.2018.11.001. eCollection 2018 Dec.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Triamicinolone | Unknown | 40 mg/ml | Other |