<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03766997</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH-breast-IGM</org_study_id>
    <nct_id>NCT03766997</nct_id>
  </id_info>
  <brief_title>Local Steroid Treatment for Idiopathic Granulomatous Mastitis (LSTIGM)</brief_title>
  <acronym>LSTIGM</acronym>
  <official_title>A Randomized Controlled Study on the Effectiveness of Local Injection Combined With Topical Steroids vs. Topical Steroids Mono-therapy in the Treatment of Idiopathic Granulomatous Mastitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the clinical response rate of local steroids in the treatment of&#xD;
      idiopathic granulomatous mastitis in female adults. Half of the participants will receive&#xD;
      local injection combined with topical steroids and the other half will receive topical&#xD;
      steroids mono-therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast disease of&#xD;
      unknown etiology.Clinical presentation of IGM can be variable. Some findings may be confused&#xD;
      with breast malignancy.&#xD;
&#xD;
      Although IGM as a disease has been known for nearly four decades, no treatment consensus has&#xD;
      been reached because of its rarity. Surgical treatment, antibiotics, oral steroids, topical&#xD;
      steroids, immunosuppression (methotrexate, mycophenolate mofetil) and close follow up have&#xD;
      all been reported to be effective.&#xD;
&#xD;
      Currently,surgical treatment and systemic steroids treatment are most frequently employed.&#xD;
      With the consideration of side effects of long term systemic (oral) steroid usage, topical&#xD;
      steroids without systemic use were assessed and showed satisfactory curative effect. But&#xD;
      there is no data concerning the use of local injection of steroids therapy on IGM.The purpose&#xD;
      of this study is to evaluate the effectiveness of steroids local injection on the basis of&#xD;
      topical steroids for IGM treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 19, 2019</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical response rate</measure>
    <time_frame>six months</time_frame>
    <description>The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>granulomatous mastitis recurrence</measure>
    <time_frame>two years</time_frame>
    <description>IGM relapses in the Ipsilateral breast.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Granulomatous Mastitis</condition>
  <arm_group>
    <arm_group_label>local injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Compound betamethasone injection (Each injection contains betamethasone dipropionate at 5 mg for betamethasone and betamethasone sodium phosphate at 2 mg for betamethasone) was local injected to the breast by the patient once a week for one to four times followed by Hydrocortisone butyrate cream(0.1%) topical use twice a day until the termination of treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>topical</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hydrocortisone butyrate 0.1% cream was applied to the breast by the patient twice a day until the termination of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Compound Betamethasone Injection</intervention_name>
    <description>local injection</description>
    <arm_group_label>local injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrocortisone Butyrate 0.1% Cream</intervention_name>
    <description>topical use</description>
    <arm_group_label>local injection</arm_group_label>
    <arm_group_label>topical</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Idiopathic Granulomatous Mastitis&#xD;
&#xD;
          -  Require non-surgical treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Breast Carcinoma&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qiang Sun, Master</last_name>
    <role>Study Director</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yanna Zhang, M.D.</last_name>
    <phone>86-10-69158703</phone>
    <email>pumchzyn@sohu.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Breast Surgery,Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qiang Sun, Master</last_name>
      <phone>86-010-69158720</phone>
      <email>sunqiangpumc@sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Yanna Zhang, Doctor</last_name>
      <phone>86-010-69158703</phone>
      <email>pumchzyn@sohu.com</email>
    </contact_backup>
    <investigator>
      <last_name>Yanna Zhang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Tahmasebi S, Karami MY, Maalhagh M. Granulomatous Mastitis: Time to Introduce New Weapons. World J Surg. 2016 Nov;40(11):2827-2828. doi: 10.1007/s00268-016-3438-9. No abstract available.</citation>
    <PMID>26920409</PMID>
  </reference>
  <reference>
    <citation>Altintoprak F, Kivilcim T, Yalkin O, Uzunoglu Y, Kahyaoglu Z, Dilek ON. Topical Steroids Are Effective in the Treatment of Idiopathic Granulomatous Mastitis. World J Surg. 2015 Nov;39(11):2718-23. doi: 10.1007/s00268-015-3147-9.</citation>
    <PMID>26148520</PMID>
  </reference>
  <reference>
    <citation>Sheybani F, Naderi HR, Gharib M, Sarvghad M, Mirfeizi Z. Idiopathic granulomatous mastitis: Long-discussed but yet-to-be-known. Autoimmunity. 2016 Jun;49(4):236-9. doi: 10.3109/08916934.2016.1138221. Epub 2016 Feb 1.</citation>
    <PMID>26829298</PMID>
  </reference>
  <reference>
    <citation>Benson JR, Dumitru D. Idiopathic granulomatous mastitis: presentation, investigation and management. Future Oncol. 2016 Jun;12(11):1381-94. doi: 10.2217/fon-2015-0038. Epub 2016 Apr 12.</citation>
    <PMID>27067146</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 1, 2020</last_update_submitted>
  <last_update_submitted_qc>December 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Granulomatous Mastitis</keyword>
  <keyword>local injection</keyword>
  <keyword>topical steroids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mastitis</mesh_term>
    <mesh_term>Granulomatous Mastitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocortisone</mesh_term>
    <mesh_term>Betamethasone</mesh_term>
    <mesh_term>Hydrocortisone-17-butyrate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03766997
org study id: PUMCH-breast-IGM
nct id: NCT03766997
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the clinical response rate of local steroids in the treatment of
      idiopathic granulomatous mastitis in female adults. Half of the participants will receive
      local injection combined with topical steroids and the other half will receive topical
      steroids mono-therapy.
Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast disease of
      unknown etiology.Clinical presentation of IGM can be variable. Some findings may be confused
      with breast malignancy.

      Although IGM as a disease has been known for nearly four decades, no treatment consensus has
      been reached because of its rarity. Surgical treatment, antibiotics, oral steroids, topical
      steroids, immunosuppression (methotrexate, mycophenolate mofetil) and close follow up have
      all been reported to be effective.

      Currently,surgical treatment and systemic steroids treatment are most frequently employed.
      With the consideration of side effects of long term systemic (oral) steroid usage, topical
      steroids without systemic use were assessed and showed satisfactory curative effect. But
      there is no data concerning the use of local injection of steroids therapy on IGM.The purpose
      of this study is to evaluate the effectiveness of steroids local injection on the basis of
      topical steroids for IGM treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: clinical response rate
time frame: six months
description: The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.
measure: granulomatous mastitis recurrence
time frame: two years
description: IGM relapses in the Ipsilateral breast.
arm group label: local injection
arm group type: Experimental
description: Compound betamethasone injection (Each injection contains betamethasone dipropionate at 5 mg for betamethasone and betamethasone sodium phosphate at 2 mg for betamethasone) was local injected to the breast by the patient once a week for one to four times followed by Hydrocortisone butyrate cream(0.1%) topical use twice a day until the termination of treatment.
arm group label: topical
arm group type: Active Comparator
description: Hydrocortisone butyrate 0.1% cream was applied to the breast by the patient twice a day until the termination of treatment.
intervention type: Drug
intervention name: Compound Betamethasone Injection
description: local injection
arm group label: local injection
intervention type: Drug
intervention name: Hydrocortisone Butyrate 0.1% Cream
description: topical use
arm group label: local injection
arm group label: topical
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Qiang Sun, Master
role: Study Director
affiliation: Peking Union Medical College Hospital
last name: Yanna Zhang, M.D.
phone: 86-10-69158703
email: pumchzyn@sohu.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
citation: Tahmasebi S, Karami MY, Maalhagh M. Granulomatous Mastitis: Time to Introduce New Weapons. World J Surg. 2016 Nov;40(11):2827-2828. doi: 10.1007/s00268-016-3438-9. No abstract available.
PMID: 26920409
citation: Altintoprak F, Kivilcim T, Yalkin O, Uzunoglu Y, Kahyaoglu Z, Dilek ON. Topical Steroids Are Effective in the Treatment of Idiopathic Granulomatous Mastitis. World J Surg. 2015 Nov;39(11):2718-23. doi: 10.1007/s00268-015-3147-9.
PMID: 26148520
citation: Sheybani F, Naderi HR, Gharib M, Sarvghad M, Mirfeizi Z. Idiopathic granulomatous mastitis: Long-discussed but yet-to-be-known. Autoimmunity. 2016 Jun;49(4):236-9. doi: 10.3109/08916934.2016.1138221. Epub 2016 Feb 1.
PMID: 26829298
citation: Benson JR, Dumitru D. Idiopathic granulomatous mastitis: presentation, investigation and management. Future Oncol. 2016 Jun;12(11):1381-94. doi: 10.2217/fon-2015-0038. Epub 2016 Apr 12.
PMID: 27067146
responsible party type: Sponsor
mesh term: Mastitis
mesh term: Granulomatous Mastitis
mesh term: Hydrocortisone
mesh term: Betamethasone
mesh term: Hydrocortisone-17-butyrate
sharing ipd: No