NCT03766997

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

February 19, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

December 3, 2020

Status Verified

December 1, 2020

Enrollment Period

1.9 years

First QC Date

December 5, 2018

Last Update Submit

December 1, 2020

Conditions

Granulomatous Mastitis

Keywords

Granulomatous Mastitislocal injectiontopical steroids

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • granulomatous mastitis recurrence

    two years

Study Arms (2)

local injection

EXPERIMENTAL

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 InjectionDrug: Hydrocortisone Butyrate 0.1% Cream

topical

ACTIVE COMPARATOR

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

Interventions

Compound Betamethasone InjectionDRUG

local injection

local injection
Hydrocortisone Butyrate 0.1% CreamDRUG

topical use

local injectiontopical

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Idiopathic Granulomatous Mastitis
  • Require non-surgical treatment

You may not qualify if:

  • Breast Carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Breast Surgery,Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (4)

  • 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: 26920409BACKGROUND

  • 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: 26148520BACKGROUND

  • 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: 26829298BACKGROUND

  • 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: 27067146BACKGROUND

MeSH Terms

Conditions

Granulomatous Mastitis

Interventions

hydrocortisone-17-butyrate

Condition Hierarchy (Ancestors)

MastitisPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Qiang Sun, Master

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Yanna Zhang, M.D.

CONTACT

86-10-69158703pumchzyn@sohu.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 6, 2018

Study Start

February 19, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

December 3, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)