Evaluation of Topical Steroids and Surgical Treatment for Idiopathic Granulomatous Mastitis
Overview
- Phase
- Phase 4
- Intervention
- Hydrocortisone Butyrate
- Conditions
- Granulomatous Mastitis
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- clinical response rate
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Idiopathic Granulomatous Mastitis
Exclusion Criteria
- •Breast Carcinoma
Arms & Interventions
medical
Hydrocortisone butyrate cream(0.1%) was applied to the breast by the patient twice a day on alternate days until the termination of treatment.
Intervention: Hydrocortisone Butyrate
surgical
lesion extended excision
Intervention: extended excision
Outcomes
Primary Outcomes
clinical response rate
Time Frame: 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 Outcomes
- granulomatous mastitis recurrence(two years)