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IRCT20100706004329N11 IRCT 2021-09-07 Tehran University of Medical Sciences imiquimod for treatment of granulomatous mastitis Assessment of the effect of local imiquimod on idiopathic granulomatous mastitis 2021-09-23 anticipated 5 Complete https://irct.ir/trial/58080 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 idiopathic granulomatous mastitis. 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-triazatricyclo[7.4.0.02,6]trideca-1(9),2(6),4,7,10,12-hexaen-7-amine. It acts as a regulator of the immune response. Imiquimod 5% cream under the brand name of Aldara is available in the market in the form of 250 ml sachets. In this treatment, imiquimod cream is applied topically on the lesion. The method of use is that a size of a fingertip of cream is placed on the finger and rubbed and spread by the patient herself on the lesion. The cream will be applied once a day. The duration of the intervention depends on the response. In case of no response, the treatment will be discontinued after 2 weeks and if there is a response, it will continue until complete recovery for a maximum of two months. The response status of the lesions will be checked every week and will be recorded in each referral. If the drug response is seen, it lasts until complete recovery, but up to a maximum of two months.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The research team has not yet decided on this matter.
public D.r Sadaf Alipour
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 salipour@sina.tums.ac.ir Tehran University of Medical Sciences scientific D.r Sadaf Alipour
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 salipour@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Female 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 N61 Inflammatory disorders of breast Treatment - Drugs 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-triazatricyclo[7.4.0.02,6]trideca-1(9),2(6),4,7,10,12-hexaen-7-amine. It acts as a regulator of the immune response. Imiquimod 5% cream under the brand name of Aldara is available in the market in the form of 250 ml sachets. In this treatment, imiquimod cream is applied topically on the lesion. The method of use is that a size of a fingertip of cream is placed on the finger and rubbed and spread by the patient herself on the lesion. The cream will be applied once a day. The duration of the intervention depends on the response. In case of no response, the treatment will be discontinued after 2 weeks and if there is a response, it will continue until complete recovery for a maximum of two months. The response status of the lesions will be checked every week and will be recorded in each referral. If the drug response is seen, it lasts until complete recovery, but up to a maximum of two months. 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. Drug Side effects. Timepoint: At the end of the study. Method of measurement: Check list. Tehran University of Medical Sciences Approved 2021-08-04 Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences Keshavarz Blvd., Imam Khomeini Hospital Complex Tehran Tehran Iran (Islamic Republic of)