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Clinical Trial Summary

This study evaluates the clinical response rate of local steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive local injection combined with topical steroids and the other half will receive topical steroids mono-therapy.


Clinical Trial Description

Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast disease of unknown etiology.Clinical presentation of IGM can be variable. Some findings may be confused with breast malignancy. Although IGM as a disease has been known for nearly four decades, no treatment consensus has been reached because of its rarity. Surgical treatment, antibiotics, oral steroids, topical steroids, immunosuppression (methotrexate, mycophenolate mofetil) and close follow up have all been reported to be effective. Currently,surgical treatment and systemic steroids treatment are most frequently employed. With the consideration of side effects of long term systemic (oral) steroid usage, topical steroids without systemic use were assessed and showed satisfactory curative effect. But there is no data concerning the use of local injection of steroids therapy on IGM.The purpose of this study is to evaluate the effectiveness of steroids local injection on the basis of topical steroids for IGM treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03766997
Study type Interventional
Source Peking Union Medical College Hospital
Contact Yanna Zhang, M.D.
Phone 86-10-69158703
Email pumchzyn@sohu.com
Status Recruiting
Phase Phase 4
Start date February 19, 2019
Completion date January 2022

See also
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Completed NCT04596046 - Could Intralesional Steroid be the Novel Treatment for Granulomatous Mastitis? N/A
Recruiting NCT02959580 - Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis Phase 4
Completed NCT04543149 - Immune Cells in Patients With Granulomatous Mastitis
Completed NCT03724903 - Ductal Lavage Versus Corticosteroids Therapy for Idiopathic Granulomatous Mastitis N/A