Granulomatous MastitisIGMNCT04596046
Could Intralesional Steroid be the Novel Treatment for Granulomatous Mastitis?
A study testing steroid injecting in people with Granulomatous Mastitis, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Idiopathic granulomatous mastitis (IGM) is a rare, benign inflammatory breast disease that mimics malignancy owing to its features of appearance.In our research, we intended to compare the efficiency of local (intralesional) steroid administration with systemic (peroral) steroid. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Granulomatous Mastitis
- What is being tested?
- steroid injecting
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Nov 2019to 17 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who were diagnosed with IGM as histopathologically
Who cannot join
- Patients who had contraindications with the use of steroids, those with active infections, as well as patients who were pregnant, and who had been diagnosed with breast cancer, were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficiency of Systemic Therapy and Intralesional Steroid Administration in the Treatment of Idiopathic Granulomatous Mastitis
Idiopathic granulomatous mastitis (IGM) is a rare, benign inflammatory breast disease that mimics malignancy owing to its features of appearance.In our research, we intended to compare the efficiency of local (intralesional) steroid administration with systemic (peroral) steroid. A total of 36 patients who had been histopathologically diagnosed with IGM and whose other factors had been microbiologically excluded were included in the study. The patients were randomized into two sub-groups that would be treated with systemic and local steroids. Of the patients, 19 were administered with 0.5-1 mg/kg/day peroral systemic steroid, and 17 were administered with 40-200 mg/ml intralesional local steroid regarding the severity of the lesion. All patients were evaluated through physical examination one week after the completion of the treatment. Subsequently, the follow-up of the patients was performed thorough physical examination and ultrasonography and/or magnetic resonance imaging at the 1st, 3rd, and 6th months.
Read the detailed description
The research was designed as a prospective randomized-controlled study.Prior to the study, approval was obtained from the local ethics committee of our hospital (reg.:162)The diagnosis of all patients was carried out through physical examination, imaging, and histopathology. Prior to the treatment, microbiological analysis was conducted concurrently with the biopsy.Patients who had contraindications with the use of steroids, those with active infections, as well as patients who were pregnant, and who had been diagnosed with breast cancer, were not included in the study. The patients were sub-divided into two groups as Group S (systemic-peroral steroid) and Group L (local-intralesional steroid) by using the sealed envelope randomization method. Group S: Medication of oral methylprednisolonewas administered to the patients following the adjustment based on the severity of the lesion and regarding the clinic. The prednisolone dose was 0.5 mg/kg/day in patients with painful, small (<5.0 cm) unilateral lesions whereas in multiple, bilateral lesions with the diameter of ≥5 cm or for those who had significant cutaneous ulceration, the prednisolone dose was specified as 1 mg/kg/day. Patients were informed about potential adverse effects. The medication was completed by reducing the dose. Patients in the systemic steroid group were advised to receive the medication after eating, to restrict salt and sugar consumption throughout the treatment, to quit smoking if they are using, and a proton pump inhibitor was started.Group L: Triamcinolone acetonidewas administered to the patients through injecting inside the lesion.The occurrence of systemic adverse effects in the course of the treatment was considered as the reason to discontinue the medication in all groups. Follow-up examinations of all patients at the 6th month were regarded as the endpoint of the treatment. As a consequence, it can be stated that the local (intralesional) steroid administration is also a treatment method, which is comparable to systemic steroid administration and had similar side effects. Nonetheless, it will be appropriate to promote this method by performing studies, which involve a larger population with more patients, and which is also long termed.
- Conditions
- Granulomatous Mastitis
- Being tested
- steroid injecting
- Keywords
- Idiopathic granulomatous mastitis, intralesional steroid, systemic steroid
- Medical subject headings
- Granulomatous Mastitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steroid injectingProcedure or surgery
Group L: Triamcinolone acetonide was administered to the patients through injecting inside the lesion.Group S: Oral methylprednisolone was administered to the patients.
| Study group | Role | What they receive |
|---|---|---|
| Group S (systemic-peroral steroid) | Active comparator | Medication of oral methylprednisolonewas administered to the patients following the adjustment based on the severity of the lesion and regarding the clinic. The prednisolone dose was 0.5 mg/kg/day in patients with painful, small (<5.0 cm) unilateral lesions whereas in multiple, bilateral lesions with the diameter of ≥5 cm or for those who had significant cutaneous ulceration, the prednisolone dose was specified as 1 mg/kg/day Receives: Procedure: steroid injecting |
| Group L (local-intralesional steroid) | Experimental | Triamcinolone acetonidewas administered to the patients through injecting inside the lesion. The practice was based on the dose of TCA administered in acute and chronic inflammatory skin lesions. If the lesion is single-focused and small (<5.0 cm), 20mg / mL TCA was injected and if the lesion is multifocal or large (>5.0 cm) then 40mg / mL TCA was injected into the lesion with the guidance of ultrasonography Receives: Procedure: steroid injecting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response to the treatment
Observational evaluation of the changes in terms of inflammation signs (hyperemia, edema, fever)
Measured: 6 month
Changes in the size of the mass
The area of a mass captured by ultrasonography was calculated in cm^2 and the change in size was reported as a percentage
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start19 Nov 2019
- Primary completion15 Jun 2020
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Granulomatous MastitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized-controlled study
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emine Yıldırım, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596046
- Sponsor's protocol ID
- 95775
- Acronym
- IGM
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2020
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Abstracts
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Systemic Therapy and Intralesional Steroid Administration in the Treatment of Idiopathic Granulomatous Mastitis
- ClinicalTrials.gov ID
- NCT04596046
- Acronym / sponsor ID
- IGM / 95775
- Conditions
- Granulomatous Mastitis
- Keywords
- Idiopathic granulomatous mastitis, intralesional steroid, systemic steroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Idiopathic granulomatous mastitis (IGM) is a rare, benign inflammatory breast disease that mimics malignancy owing to its features of appearance.In our research, we intended to compare the efficiency of local (intralesional) steroid administration with systemic (peroral) steroid. A total of 36 patients who had been histopathologically diagnosed with IGM and whose other factors had been microbiologically excluded were included in the study. The patients were randomized into two sub-groups that would be treated with systemic and local steroids. Of the patients, 19 were administered with 0.5-1 mg/kg/day peroral systemic steroid, and 17 were administered with 40-200 mg/ml intralesional local steroid regarding the severity of the lesion. All patients were evaluated through physical examination one week after the completion of the treatment. Subsequently, the follow-up of the patients was performed thorough physical examination and ultrasonography and/or magnetic resonance imaging at the 1st, 3rd, and 6th months.
Detailed description
The research was designed as a prospective randomized-controlled study.Prior to the study, approval was obtained from the local ethics committee of our hospital (reg.:162)The diagnosis of all patients was carried out through physical examination, imaging, and histopathology. Prior to the treatment, microbiological analysis was conducted concurrently with the biopsy.Patients who had contraindications with the use of steroids, those with active infections, as well as patients who were pregnant, and who had been diagnosed with breast cancer, were not included in the study. The patients were sub-divided into two groups as Group S (systemic-peroral steroid) and Group L (local-intralesional steroid) by using the sealed envelope randomization method. Group S: Medication of oral methylprednisolonewas administered to the patients following the adjustment based on the severity of the lesion and regarding the clinic. The prednisolone dose was 0.5 mg/kg/day in patients with painful, small (<5.0 cm) unilateral lesions whereas in multiple, bilateral lesions with the diameter of ≥5 cm or for those who had significant cutaneous ulceration, the prednisolone dose was specified as 1 mg/kg/day. Patients were informed about potential adverse effects. The medication was completed by reducing the dose. Patients in the systemic steroid group were advised to receive the medication after eating, to restrict salt and sugar consumption throughout the treatment, to quit smoking if they are using, and a proton pump inhibitor was started.Group L: Triamcinolone acetonidewas administered to the patients through injecting inside the lesion.The occurrence of systemic adverse effects in the course of the treatment was considered as the reason to discontinue the medication in all groups. Follow-up examinations of all patients at the 6th month were regarded as the endpoint of the treatment. As a consequence, it can be stated that the local (intralesional) steroid administration is also a treatment method, which is comparable to systemic steroid administration and had similar side effects. Nonetheless, it will be appropriate to promote this method by performing studies, which involve a larger population with more patients, and which is also long termed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized-controlled study
| Arm | Type | Receives |
|---|---|---|
| Group S (systemic-peroral steroid) | Active comparator | Procedure: steroid injectingMedication of oral methylprednisolonewas administered to the patients following the adjustment based on the severity of the lesion and regarding the clinic. The prednisolone dose was 0.5 mg/kg/day in patients with painful, small (<5.0 cm) unilateral lesions whereas in multiple, bilateral lesions with the diameter of ≥5 cm or for those who had significant cutaneous ulceration, the prednisolone dose was specified as 1 mg/kg/day |
| Group L (local-intralesional steroid) | Experimental | Procedure: steroid injectingTriamcinolone acetonidewas administered to the patients through injecting inside the lesion. The practice was based on the dose of TCA administered in acute and chronic inflammatory skin lesions. If the lesion is single-focused and small (<5.0 cm), 20mg / mL TCA was injected and if the lesion is multifocal or large (>5.0 cm) then 40mg / mL TCA was injected into the lesion with the guidance of ultrasonography |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were diagnosed with IGM as histopathologically
Key exclusion criteria (1 listed)
- Patients who had contraindications with the use of steroids, those with active infections, as well as patients who were pregnant, and who had been diagnosed with breast cancer, were not included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| steroid injectingGroup L: Triamcinolone acetonide was administered to the patients through injecting inside the lesion.Group S: Oral methylprednisolone was administered to the patients. | Procedure or surgery | Group L (local-intralesional steroid), Group S (systemic-peroral steroid) |
Primary outcome
Clinical response to the treatment
Time frame: 6 month
Observational evaluation of the changes in terms of inflammation signs (hyperemia, edema, fever)
Changes in the size of the mass
Time frame: 6 month
The area of a mass captured by ultrasonography was calculated in cm^2 and the change in size was reported as a percentage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No. Abstracts
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing steroid injecting in people with Granulomatous Mastitis, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response to the treatment (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.