Local Steroid Treatment for Idiopathic Granulomatous Mastitis (LSTIGM)

Granulomatous Mastitis Clinical Trial

— LSTIGM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03766997
• Other study ID #: PUMCH-breast-IGM
• Status: Recruiting
• Phase: Phase 4
• Start date: February 19, 2019
• Est. completion date: January 2022

Study information

• Verified date: December 2020
• Source: Peking Union Medical College Hospital
• Contact: Yanna Zhang, M.D.
• Phone: 86-10-69158703
• Email: pumchzyn[@]sohu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2022
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Idiopathic Granulomatous Mastitis

• Require non-surgical treatment

Exclusion Criteria:

• Breast Carcinoma

Related Conditions & MeSH terms

• Granulomatous Mastitis
• Mastitis

Intervention

Drug:
• Compound Betamethasone Injection
local injection
• Hydrocortisone Butyrate 0.1% Cream
topical use

Locations

Country	Name	City	State
China	Department of Breast Surgery,Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. Review. — View 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. Review. — View Citation

Tahmasebi S, Karami MY, Maalhagh M. Granulomatous Mastitis: Time to Introduce New Weapons. World J Surg. 2016 Nov;40(11):2827-2828. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical response rate	The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.	six months
Secondary	granulomatous mastitis recurrence	IGM relapses in the Ipsilateral breast.	two years