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Clinical Trials/IRCT20230822059222N1
IRCT20230822059222N1
Not yet recruiting
Phase 2

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

Shiraz University of Medical Sciences0 sites40 target enrollmentTBD

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Shiraz University of Medical Sciences
Enrollment
40
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • A confirmed diagnosis of idiopathic granulomatous mastitis (IGM) based on histopathological examination
  • The patients should require non\-surgical treatment for their condition
  • The severity of involvement should be grade II, III, or IV according to the modified classification of Yuan et al
  • Absent of breast carcinoma or other malignancies or systemic diseases such as vasculitis, collagen vascular disease, or sarcoidosis
  • Absent of a risk factor for steroid therapy, such as hypertension or diabetes mellitus

Exclusion Criteria

  • Lack of consent to participate in the study
  • The severity of the conflict is grade 1

Outcomes

Primary Outcomes

Not specified

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