Effectiveness of Local Injection (Bethametasone LA) combined with Systemic therapy (Methotraxate and Prednisolone)and Topical Steroids injection alone or Systemic therapy alone in the Treatment of Idiopathic Granulomatous Mastitis

A Randomized Controlled Trial Study on the Effectiveness of Local Injection combined with with Systemic therapy and Topical Steroids injection alone or Systemic therapy alone in the Treatment of Idiopathic Granulomatous Mastitis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200608047694N1

Enrollment

Registered

2020-07-21

Start date

2020-05-23

Completion date

Unknown

Last updated

2020-08-17

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

Conditions

Idiopathic Granulomatous Mastitis. Inflammatory disorders of breast

Interventions

Intervention 1: Group one (N=30, systemic therapy plus local steroid injection) will be treated with Local steroid injection to the breast by the physician once a week for one to four times (betametha

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Female patients with Idiopathic Granulomatosis Mastitis Female patients aged 18-65 Female patients with Idiopathic Granulomatosis Mastitis which require non-surgical treatment

Exclusion criteria

Exclusion criteria: Female patients with Idiopathic Granulomatosis Mastitis who has abcess Female patients with Idiopathic Granulomatosis Mastitis which require surgical intervention or has breast cancer or other malignancy

Design outcomes

Primary

Measure	Time frame
The disappearance of inflammatory signs. Timepoint: All Patients will be followed weekly in first month and then monthly for 5 months for detect symptoms. Method of measurement: The clinical response is categorized into completely healed, inadequately healed, stable, worsened, or relapsed that will be evaluated by surgeon.;Closure of fistula orifices. Timepoint: All Patients will be followed weekly in the first month and then monthly for 5 months to detect symptoms. Method of measurement: The clinical response is categorized into completely healed, inadequately healed, stable, and worsened that will be evaluated by the surgeon.;Disappearance of skin erosion. Timepoint: All Patients will be followed weekly in the first month and then monthly for 5 months to detect symptoms. Method of measurement: The clinical response is categorized into completely healed, inadequately healed, stable, and worsened that will be evaluated by the surgeon.	—

Measure

Time frame

The disappearance of inflammatory signs. Timepoint: All Patients will be followed weekly in first month and then monthly for 5 months for detect symptoms. Method of measurement: The clinical response is categorized into completely healed, inadequately healed, stable, worsened, or relapsed that will be evaluated by surgeon.;Closure of fistula orifices. Timepoint: All Patients will be followed weekly in the first month and then monthly for 5 months to detect symptoms. Method of measurement: The clinical response is categorized into completely healed, inadequately healed, stable, and worsened that will be evaluated by the surgeon.;Disappearance of skin erosion. Timepoint: All Patients will be followed weekly in the first month and then monthly for 5 months to detect symptoms. Method of measurement: The clinical response is categorized into completely healed, inadequately healed, stable, and worsened that will be evaluated by the surgeon.

—

Secondary

Measure	Time frame
Granulomatous mastitis recurrence in the Ipsilateral breast. Timepoint: All Patients will be exam by surgeon and sonography will be done for all of them at the last month of follow up. Method of measurement: The occurrence of Granulomatosis Mastitis will be assessed by the surgeon and doing sonography.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactVahid Zangouri

Shiraz University of Medical Sciences

zangouri@sums.ac.ir+98 71 3612 1000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026