Local Steroid Treatment for Idiopathic Granulomatous Mastitis (LSTIGM)

Phase 4

• Conditions: Granulomatous Mastitis
• Interventions: Drug: Compound Betamethasone Injection; Drug: Hydrocortisone Butyrate 0.1% Cream

• Registration Number: NCT03766997
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-06
• Study Start: 2019-02-19
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-03
• Primary Completion: 2021-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Idiopathic Granulomatous Mastitis
• Require non-surgical treatment

Exclusion Criteria

• Breast Carcinoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
local injection	Hydrocortisone Butyrate 0.1% Cream	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.
topical	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.
local injection	Compound Betamethasone Injection	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.

Primary Outcome Measures

Name	Time	Method
clinical response rate	six months	The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.

Secondary Outcome Measures

Name	Time	Method
granulomatous mastitis recurrence	two years	IGM relapses in the Ipsilateral breast.

Trial Locations

Locations (1)

Department of Breast Surgery,Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China