A Randomized Clinical Trial to Evaluate the Efficacy of Systemic Treatment in Combination with Topical Tacrolimus versus Systemic Treatment Alone in Managing Skin Involvement of Patients with Idiopathic Granulomatous Mastitis
This study aims to evaluate the efficacy of systemic treatment in combination with topical steroids versus systemic treatment alone in managing skin involvement of patients with Idiopathic Granulomatous Mastitis
Design
In a randomized clinical trial with three intervention parallel groups, 36 patients will be enrolled in phase 2. Random Allocation Software will be used for block randomization.
Settings and conduct
This study will be conducted in the Breast Diseases Research Center in Shiraz. Patients will be allocated into one of the two groups. Group one will be treated with oral systemic treatment. Group two will be treated with oral systemic treatment followed by topical Tacrolimus.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female patients with idiopathic granulomatous mastitis between the ages of 18 and 65 who do not have diabetes, hypertension, other autoimmune diseases, breast cancer, or other malignancies that do not require surgical treatment. Exclusion criteria: Lack of consent to participate in the study and grade I disease severity
Intervention groups
All Patients will be treated with 2-week oral antibiotics (Ciprofloxacin, Metronidazole). The patients will be allocated to two study groups, randomly. Group one will be treated with systemic oral corticosteroid and MTX as systemic treatment. Group two will be treated with systemic oral corticosteroids and MTX as systemic treatment followed by daily usage of topical Tacrolimus ointment once a day.
Main outcome variables
Disappearance of inflammatory signs, closure of fistula orifices, and skin erosions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230822059222N2
Registration date:2024-04-14, 1403/01/26
Registration timing:registered_while_recruiting
Last update:2024-04-14, 1403/01/26
Update count:0
Registration date
2024-04-14, 1403/01/26
Registrant information
Name
Aliyeh Ranjbar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3481 4336
Email address
aliyeh.ranjbar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-02, 1403/01/14
Expected recruitment end date
2024-05-03, 1403/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized Clinical Trial to Evaluate the Efficacy of Systemic Treatment in Combination with Topical Tacrolimus versus Systemic Treatment Alone in Managing Skin Involvement of Patients with Idiopathic Granulomatous Mastitis
Public title
Topical Tacrolimus in Managing Skin Involvement of Patients with Idiopathic Granulomatous Mastitis.
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will employ stratified block randomization to ensure an even distribution of patients by disease grade. We will enroll 8 patients in grade 2, 16 in grade 3, and 12 in grade 4. Then, we will use a block randomization method with blocks containing 4 patients each to randomly assign patients to either the intervention or control group within each disease grade.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee for Ethics in Biomedical Research of school of Medicine - Shiraz University of Me
Street address
Breast Disease Research Center, Shahid Motahari Clinic, Namazi Square, Karimkhan Zand Street
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸-۷۱۴۷۳۷
Approval date
2023-04-15, 1402/01/26
Ethics committee reference number
IR.SUMS.MED.REC.1402.563
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
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.
2
Description
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
3
Description
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 outcomes
1
Description
Resolution of skin involvement
Timepoint
One year after starting the treatment
Method of measurement
Assessed by the surgeon
Intervention groups
1
Description
Intervention group: The systemic treatment regimen will be adjusted based on the severity of the disease, as follows:- Grade II: Oral prednisolone with a starting dose of 30-20 mg/day, tapered over 6-8 weeks. In addition to prednisolone, 5 mg of oral methotrexate will be administered weekly.- Grade III: Oral prednisolone with a starting dose of 50-40 mg/day, tapered over 20-24 weeks. In addition to prednisolone, 15 mg of oral methotrexate will be administered weekly.- Grade IV: Oral prednisolone with a starting dose of 60-50 mg/day, tapered over 20-30 weeks. In addition to prednisolone, 15 mg of oral methotrexate will be administered weekly. For the first two weeks of treatment, a combination of antibiotics (ciprofloxacin 500 mg every 12 hours and metronidazole every 8 hours) will be used. All patients will receive daily administration of calcium-D and folic acid supplements to prevent osteoporosis and folate deficiency. Topical treatment: The topical treatment will consist of the application of Tacrolimus ointment twice a day for 2-6 months according to severity.
Category
Treatment - Drugs
2
Description
Control group: The systemic treatment regimen will be adjusted based on the severity of the disease, as follows:- Grade II: Oral prednisolone with a starting dose of 30-20 mg/day, tapered over 6-8 weeks. In addition to prednisolone, 5 mg of oral methotrexate will be administered weekly.- Grade III: Oral prednisolone with a starting dose of 50-40 mg/day, tapered over 20-24 weeks. In addition to prednisolone, 15 mg of oral methotrexate will be administered weekly.- Grade IV: Oral prednisolone with a starting dose of 60-50 mg/day, tapered over 20-30 weeks. In addition to prednisolone, 15 mg of oral methotrexate will be administered weekly. For the first two weeks of treatment, a combination of antibiotics (ciprofloxacin 500 mg every 12 hours and metronidazole every 8 hours) will be used. All patients will receive daily administration of calcium-D and folic acid supplements to prevent osteoporosis and folate deficiency.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Breast Diseases Research Center
Full name of responsible person
Vahid Zangouri
Street address
Shahid Motahari Clinic, Namazi Square, Karimkhan Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3612 1000
Email
zangouri@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Shiraz University of Medical Sciences, Karrimkhan Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Fax
Email
hashempur@gmail.com
Grant name
Department of Research of Shiraz University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Vahid Zangouri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Motahari Clinic, Namazi Square, Karimkhan Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3612 1000
Email
zangouri@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vahid Zangouri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Motahari Clinic, Namazi Square, Karimkhan Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3612 1000
Email
zangouri@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Aliyeh Ranjbar
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Breast Disease Research Center, Shahid Motahari Clinic, Namazi Square, Karimkhan Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3612 1000
Email
aliyeh.ranjbar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome of the study will be shared while maintaining the confidentiality of patient information.
When the data will become available and for how long
Data will be available,3months after publication
To whom data/document is available
Researchers affiliated with academic institutions
Under which criteria data/document could be used
The use of data from this study in the form of higher and more complete sample size studies is not prohibited
From where data/document is obtainable
Breast Diseases Research Center, Shahid Motahhrai Clinic affiliated with Shiraz University of Medical Sciences
What processes are involved for a request to access data/document
Referring to the Breast Diseases Research Center and after applying the request, the request will be evaluated in the approved meetings.