A Phase 4 interventional study of Hydrocortisone Butyrate and extended excision in Granulomatous Mastitis, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-12-06.
Sponsored by Peking Union Medical College Hospital · Phase 4, Interventional, and Treatment
This study evaluates the clinical response rate of topical steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive topical steroid and the other half will receive local wide surgical excision.
Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast disease of unknown etiology.It may present with many findings that clinically and radiologically mimic breast cancer.
Although IGM as a disease has been known for nearly four decades, the optimal treatment approach has not been established. Surgical intervention in the form of wide surgical excision was the mainstay of treatment before 1980, and is still performed depending on local expertise and preference.
Currently,surgical treatment and systemic steroid treatment are frequently employed. With the consideration of side effects of longterm systemic (oral) steroid usage, topical steroid without systemic use were assessed and showed satisfactory curative effect. But the data concerning the use of topical steroid therapy are still very limited.
22 studies on the registry are indexed under Granulomatous Mastitis; 7 are open to participants now.
This study's planned enrollment of 100 is above the median of 61 across 12 interventional studies indexed under Granulomatous Mastitis.
Browse Granulomatous Mastitis studies →Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Hydrocortisone butyrate cream(0.1%) was applied to the breast by the patient twice a day on alternate days until the termination of treatment.
Drug: Hydrocortisone Butyrate
lesion extended excision
Procedure: extended excision
topical use
Lesion extended excision with or without a random breast dermo-glandular flap (BDGF).
clinical response rate
The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.
Time frame: six months
granulomatous mastitis recurrence
Time frame: two years
Plan to share: No
Started Jan 2017 (actual). Primary completion is estimated for Sep 2020, 44 months after the start.
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This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydrocortisone butyrate
Peking Union Medical College Hospital →