imiquimod for treatment of granulomatous mastitis

Assessment of the effect of local imiquimod on idiopathic granulomatous mastitis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100706004329N11

Enrollment

Registered

2021-09-07

Start date

2021-09-23

Completion date

Unknown

Last updated

2021-11-01

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 group: imiquimod topical cream will be applied once a day, topically on the whole lesion. imiquimod is an imidazo-quinolin and its structural formula includes 3-(2-Methylpropyl)-3,5,8-tri

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Diagnosis of granulomatous mastitis based on pathological examination of lesions Refractory to common treatments including anti-inflammatory drugs, corticosteroids or colchicine and antibiotics after one month of treatment Presence of erythema or fistula

Exclusion criteria

Exclusion criteria: Presence of active ulcers Abscess History of use and allergy to imiquimod Cases where the disease involves only a deep mass and has no superficial manifestations

Design outcomes

Primary

Measure	Time frame
Erythema. Timepoint: At the beginning of the study (before the intervention) and then once a week until the end of the intervention. Method of measurement: Examination.;Ulcers. Timepoint: At the beginning of the study (before the intervention) and then once a week until the end of the intervention. Method of measurement: Examination.;Fistula. Timepoint: At the beginning of the study (before the intervention) and then once a week until the end of the intervention. Method of measurement: Examination.;Mass. Timepoint: At the beginning of the study (before the intervention) and then once a week until the end of the intervention. Method of measurement: Examination.;Tissue thickness. Timepoint: At the beginning of the study (before the intervention) and then once a week until the end of the intervention. Method of measurement: Examination.;Number of lesions. Timepoint: At the beginning of the study (before the intervention) and then once a week until the end of the intervention. Method of measurement: Examination.;Size of lesions. Timepoint: At the beginning of the study (before the intervention) and then once a week until the end of the intervention. Method of measurement: Examination.	—

Measure

Time frame

Erythema. Timepoint: At the beginning of the study (before the intervention) and then once a week until the end of the intervention. Method of measurement: Examination.;Ulcers. Timepoint: At the beginning of the study (before the intervention) and then once a week until the end of the intervention. Method of measurement: Examination.;Fistula. Timepoint: At the beginning of the study (before the intervention) and then once a week until the end of the intervention. Method of measurement: Examination.;Mass. Timepoint: At the beginning of the study (before the intervention) and then once a week until the end of the intervention. Method of measurement: Examination.;Tissue thickness. Timepoint: At the beginning of the study (before the intervention) and then once a week until the end of the intervention. Method of measurement: Examination.;Number of lesions. Timepoint: At the beginning of the study (before the intervention) and then once a week until the end of the intervention. Method of measurement: Examination.;Size of lesions. Timepoint: At the beginning of the study (before the intervention) and then once a week until the end of the intervention. Method of measurement: Examination.

—

Secondary

Measure	Time frame
Drug Side effects. Timepoint: At the end of the study. Method of measurement: Check list.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactD.r Sadaf Alipour

Tehran University of Medical Sciences

salipour@sina.tums.ac.ir+98 21 7771 9922

Outcome results

None listed

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