Topical Tacrolimus in Managing Skin Involvement of Patients with Idiopathic Granulomatous Mastitis.

A Randomized Clinical Trial to Evaluate the Efficacy of Systemic Treatment in Combination with Topical Tacrolimus versus Systemic Treatment Alone in Managing Skin Involvement of Patients with Idiopathic Granulomatous Mastitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230822059222N2

Enrollment

Registered

2024-04-14

Start date

2024-04-02

Completion date

Unknown

Last updated

2024-05-27

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: Intervention group: The systemic treatment regimen will be adjusted based on the severity of the disease, as follows:- Grade II: Oral prednisolone with a starting dose of 30-20 mg/day,

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: A confirmed diagnosis of idiopathic granulomatous mastitis (IGM) based on histopathological examination The severity of involvement should be grade II, III, or IV according to the modified classification of Yuan et al consent to participate in the study

Exclusion criteria

Exclusion criteria: breast carcinoma or other malignancies require surgical treatment systemic diseases such as vasculitis, collagen vascular disease, or sarcoidosis a risk factor for steroid therapy, such as hypertension or diabetes mellitus pregnancy

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, worsened, or relapsed that will be evaluated by 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, worsened, or relapsed that will be evaluated by 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, worsened, or relapsed that will be evaluated by 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, worsened, or relapsed that will be evaluated by surgeon.

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Secondary

Measure	Time frame
Resolution of skin involvement. Timepoint: One year after starting the treatment. Method of measurement: Assessed by the surgeon.	—

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