Determining the effect of topical application of Imiquimod in the treatment of resistant granulomatous mastitis
Design
A Phase two Clinical trial, without a control group, on 5 patients.
Settings and conduct
Setting: Arash Women's Hospital
5 eligible patients with refractory granulomatous will be included into the study after obtaining written consent and the desired intervention will be performed on them as described in the relevant section.
Randomization and Blinding: Since there is only one intervention group, randomization and blinding are not applicable.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Granulomatous mastitis resistant to common treatments
Exclusion criteria: Wounds or abscesses, allergy to Imiquimod
Intervention groups
The intervention group includes 5 patients with refractory granulomatous mastitis who will receive Imiquimod cream topically, once a day until the regression of lesions (up to two months).
Main outcome variables
Erythema size; Number of fistulas; Mass size or tissue stiffness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100706004329N11
Registration date:2021-09-07, 1400/06/16
Registration timing:prospective
Last update:2021-09-07, 1400/06/16
Update count:0
Registration date
2021-09-07, 1400/06/16
Registrant information
Name
Sadaf Alipour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982177888751 - 00982177883195
Email address
salipour@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of local imiquimod on idiopathic granulomatous mastitis
Public title
imiquimod for treatment of granulomatous mastitis
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
Keshavarz Blvd., Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-08-04, 1400/05/13
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.180
Health conditions studied
1
Description of health condition studied
idiopathic granulomatous mastitis
ICD-10 code
N61
ICD-10 code description
Inflammatory disorders of breast
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
5
Description
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
6
Description
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
7
Description
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 outcomes
1
Description
Drug Side effects
Timepoint
At the end of the study
Method of measurement
Check list
Intervention groups
1
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women 's Hospital
Full name of responsible person
Sadaf Alipour, Professor of Surgery
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Email
hosparash@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
6th floor, Central University, Qods St, Keshavarz Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8838 8988
Fax
+98 21 8838 8988
Email
resdeputy@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
D.r Sadaf Alipour
Position
Professor of Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
Email
salipour@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
D.r Sadaf Alipour
Position
Professor of Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
Email
salipour@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
D.r Sadaf Alipour
Position
Professor of Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
Email
salipour@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available