Local Steroid Treatment for Idiopathic Granulomatous Mastitis (LSTIGM)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 4

Conditions: Granulomatous Mastitis

Treatments: Drug: Hydrocortisone Butyrate 0.1% Cream; Drug: Compound Betamethasone Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03766997

PUMCH-breast-IGM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Idiopathic Granulomatous Mastitis
• Require non-surgical treatment

Exclusion criteria

• Breast Carcinoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

local injection

Experimental group

Description:

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.

Treatment:

Drug: Compound Betamethasone Injection

Drug: Hydrocortisone Butyrate 0.1% Cream

topical

Active Comparator group

Description:

Hydrocortisone butyrate 0.1% cream was applied to the breast by the patient twice a day until the termination of treatment.

Treatment:

Drug: Hydrocortisone Butyrate 0.1% Cream