NCT02959580

Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis

Evaluation of Topical Steroids and Surgical Treatment for Idiopathic Granulomatous Mastitis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Granulomatous Mastitis

Interventions

Type	Name	Description
DRUG	Hydrocortisone Butyrate	topical use
PROCEDURE	extended excision	Lesion extended excision with or without a random breast dermo-glandular flap (BDGF).

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2016-11-09
• Last updated: 2018-12-06

Locations

1 site across 1 country: China