Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis
NCT ID: NCT02959580
Last Updated: 2018-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2017-01-01
2020-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Local Steroid Treatment for Idiopathic Granulomatous Mastitis (LSTIGM)
NCT03766997
Ductal Lavage Versus Corticosteroids Therapy for Idiopathic Granulomatous Mastitis
NCT03724903
Could Intralesional Steroid be the Novel Treatment for Granulomatous Mastitis?
NCT04596046
Idiopathic Granulomatous Mastitis Combination Therapy
NCT05361629
Granulomatous Mastitis Current Approach and Treatment
NCT02667132
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Although IGM as a disease has been known for nearly four decades, the optimal treatment approach has not been established. Surgical intervention in the form of wide surgical excision was the mainstay of treatment before 1980, and is still performed depending on local expertise and preference.
Currently,surgical treatment and systemic steroid treatment are frequently employed. With the consideration of side effects of longterm systemic (oral) steroid usage, topical steroid without systemic use were assessed and showed satisfactory curative effect. But the data concerning the use of topical steroid therapy are still very limited.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
medical
Hydrocortisone butyrate cream(0.1%) was applied to the breast by the patient twice a day on alternate days until the termination of treatment.
Hydrocortisone Butyrate
topical use
surgical
lesion extended excision
extended excision
Lesion extended excision with or without a random breast dermo-glandular flap (BDGF).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hydrocortisone Butyrate
topical use
extended excision
Lesion extended excision with or without a random breast dermo-glandular flap (BDGF).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking Union Medical College Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Qiang Sun, master
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Breast Surgery,Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PUMCH-breast-mastitis
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.