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Local Steroid Treatment for Idiopathic Granulomatous Mastitis (LSTIGM) (LSTIGM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03766997
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : February 22, 2019
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Granulomatous Mastitis Drug: Compound Betamethasone Injection Drug: Hydrocortisone Butyrate 0.1% Cream Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Arm Intervention/treatment
Experimental: local injection
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.
Drug: Compound Betamethasone Injection
local injection

Drug: Hydrocortisone Butyrate 0.1% Cream
topical use

Active Comparator: topical
Hydrocortisone butyrate 0.1% cream was applied to the breast by the patient twice a day until the termination of treatment.
Drug: Hydrocortisone Butyrate 0.1% Cream
topical use

Primary Outcome Measures :
  1. clinical response rate [ Time Frame: six months ]
    The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.

Secondary Outcome Measures :
  1. granulomatous mastitis recurrence [ Time Frame: two years ]
    IGM relapses in the Ipsilateral breast.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Idiopathic Granulomatous Mastitis
  • Require non-surgical treatment

Exclusion Criteria:

  • Breast Carcinoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03766997

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Contact: Yanna Zhang, M.D. 86-10-69158703

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China, Beijing
Department of Breast Surgery,Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Qiang Sun, Master    86-010-69158720   
Contact: Yanna Zhang, Doctor    86-010-69158703   
Principal Investigator: Yanna Zhang, M.D.         
Sponsors and Collaborators
Peking Union Medical College Hospital
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Study Director: Qiang Sun, Master Peking Union Medical College Hospital

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Responsible Party: Peking Union Medical College Hospital Identifier: NCT03766997    
Other Study ID Numbers: PUMCH-breast-IGM
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking Union Medical College Hospital:
Granulomatous Mastitis
local injection
topical steroids
Additional relevant MeSH terms:
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Granulomatous Mastitis
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents