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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 13 January 2020
Main ID:  ChiCTR2000029007
Date of registration: 2020-01-11
Prospective Registration: No
Primary sponsor: The First Affiliated Hospital of Kunming Medical University
Public title: Clinical observation of subclinical dosage of cyclosporine combined with glucocorticoid in the treatment of moderate and severe bullous pemphigoid
Scientific title: Clinical observation of subclinical dosage of cyclosporine combined with glucocorticoid in the treatment of moderate and severe bullous pemphigoid
Date of first enrolment: 2020-01-01
Target sample size: experimental group:30;control group:30;
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=44128
Study type:  Interventional study
Study design:  Parallel  
Phase:  4
Countries of recruitment
China
Contacts
Name: Li He   
Address:  295 Xichang Road, Kunming, Yunnan, China
Telephone: +86 13577098206
Email: drheli2662@126.com
Affiliation:  The First Affiliated Hospital of Kunming Medical University
Name: Tongyun Liu   
Address:  295 Xichang Road, Kunming, Yunnan, China
Telephone: +86 15825286735
Email: tongyun91@126.com
Affiliation:  The First Affiliated Hospital of Kunming Medical University
Key inclusion & exclusion criteria
Inclusion criteria: 1. Age:18-64,both gender,blood routines and urine routines are normal,without the liver function lesion and kidney lesion;
2. Meet diagnostic criteria of moderate and severe bullous pemphigoid;
3. No immunosuppressants were used in the first 3 months and there are no contraindications for the use of cyclosporine;
4. Complete the whole study according to the requirements of the study and can follow up as required;
5. The informed consent has been signed and willing to complete the research process.

Exclusion criteria: 1. Pregnancy,lactating mother,a woman of child-bearing age who has fertility requirements;
2. WBC < 3.5 x 10^9/L;
3. Severe liver and kidney damage;
4. There are contraindications to the use of glucocorticoids or cyclosporine;
5. Patients with bullous pemphigoid who have been treated and stable patient;
6. Patients who are currently participating in other clinical studies or who have participated in other clinical studies within 3 months.


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Bullous Pemphigoid
Intervention(s)
experimental group:subclinical dosage of Cyclosporine, Prednisone or Methylprednisolone and Halometasone Cream.;control group:Prednisone or Methylprednisolone, Halometasone Cream;
Primary Outcome(s)
BP180;BP230;
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Yunnan clinical medical research center for skin immune diseases
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 21/12/2019
Contact:
Ting Wang
Results
Results available:
Date Posted:
Date Completed:
URL:
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