Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis

Evaluation of Topical Steroids and Surgical Treatment for Idiopathic Granulomatous Mastitis

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02959580

Acronym

MSTIGM

Enrollment

100

Registered

2016-11-09

Start date

2017-01-01

Completion date

2020-09-30

Last updated

2018-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Granulomatous Mastitis

Keywords

Granulomatous, Mastitis, topical steroids

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.

Interventions

DRUGHydrocortisone Butyrate

topical use

PROCEDUREextended excision

Lesion extended excision with or without a random breast dermo-glandular flap (BDGF).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Idiopathic Granulomatous Mastitis

Exclusion criteria

* Breast Carcinoma

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
granulomatous mastitis recurrence	two years

Countries

China

Contacts

Primary ContactYanna Zhang, M.D.

pumchzyn@sohu.com86-10-69158703

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026