A Phase 4 interventional study of Compound Betamethasone Injection and Hydrocortisone Butyrate 0.1% Cream 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 2020-12-03.
Sponsored by Peking Union Medical College Hospital · Phase 4, Interventional, and Treatment
Among 10 studies in Granulomatous Mastitis with a site in China — 2 open to participants now, 3 under way, none of them phase 3. Granulomatous Mastitis · China.
Among the 10 studies in Granulomatous Mastitis with a site in China, this one is one of 3 that started in 2019, is one of 2 in phase 4, and was the 3rd registered.
22 studies on the registry are indexed under Granulomatous Mastitis; 7 are open to participants now.
Browse Granulomatous Mastitis studies →2 of the 10 studies in Granulomatous Mastitis with a site in China are open now. Recruiting first, the newest first:
Hubei Cancer Hospital · Sites in China
Ages 18+ · Women only
Wuhan University · Sites in China
Ages 18–60 · Women only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 2 Granulomatous Mastitis studies recruiting now, 2 set no upper age limit and none stop at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 18 Years to 60 Years · female · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 3 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 61 across 12 interventional studies indexed under Granulomatous Mastitis.
Median enrollment 100 across the 6 interventional studies, 210 across the 4 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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None of the 10 has an industry lead sponsor. The 6 most frequent:
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.
Peking Union Medical College Hospital has 2 studies filed under Granulomatous Mastitis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Granulomatous Mastitis with a site in China, from their registry updates:
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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.
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.
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Exclusion Criteria:
Compound betamethasone injection (Each injection contains betamethasone dipropionate at 5 mg for betamethasone and betamethasone sodium phosphate at 2 mg for betamethasone) was local injected to the breast by the patient once a week for one to four times followed by Hydrocortisone butyrate cream(0.1%) topical use twice a day until the termination of treatment.
Drug: Compound Betamethasone Injection · Drug: Hydrocortisone Butyrate 0.1% Cream
Hydrocortisone butyrate 0.1% cream was applied to the breast by the patient twice a day until the termination of treatment.
Drug: Hydrocortisone Butyrate 0.1% Cream
local injection
topical use
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
IGM relapses in the Ipsilateral breast.
Time frame: two years
Plan to share: No
Started Feb 2019 (actual). Primary completion is estimated for Jan 2021, 23 months after the start.
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This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital →