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

Phase 2

Conditions: Idiopathic Granulomatous Mastitis.
Inflammatory disorders of breast

Registration Number: IRCT20230822059222N2

Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 36

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures