Local Steroid Treatment for Idiopathic Granulomatous Mastitis (LSTIGM)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Study on the Effectiveness of Local Injection Combined With Topical Steroids vs. Topical Steroids Mono-therapy in the Treatment of Idiopathic Granulomatous Mastitis

Conditions
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Granulomatous Mastitis

Intervention / Treatment
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* Drug: Compound Betamethasone Injection
* Drug: Hydrocortisone Butyrate 0.1% Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic Granulomatous Mastitis Require non-surgical treatment Exclusion Criteria: Breast Carcinoma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: local injection<br>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<br>* local injection<br>Drug: Hydrocortisone Butyrate 0.1% Cream<br>* topical use<br>|
| Active Comparator: topical<br>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<br>* topical use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| granulomatous mastitis recurrence | IGM relapses in the Ipsilateral breast. | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Granulomatous Mastitis, local injection, topical steroids