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Local Steroid Treatment for Idiopathic Granulomatous Mastitis (LSTIGM)

A Randomized Controlled Study on the Effectiveness of Local Injection Combined With Topical Steroids vs. Topical Steroids Mono-therapy in the Treatment of Idiopathic Granulomatous Mastitis

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03766997
Acronym
LSTIGM
Enrollment
100
Registered
2018-12-06
Start date
2019-02-19
Completion date
2022-01-31
Last updated
2020-12-03

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, local injection, topical steroids

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.

Interventions

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Idiopathic Granulomatous Mastitis * Require non-surgical treatment

Exclusion criteria

* Breast Carcinoma

Design outcomes

Primary

MeasureTime frameDescription
clinical response ratesix monthsThe clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.

Secondary

MeasureTime frameDescription
granulomatous mastitis recurrencetwo yearsIGM relapses in the Ipsilateral breast.

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