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Use of inravenous Methotrexate plus Glucocorticoid for the Treatment of bullous pemphigoid:A multicenter,randomized and controlled clinincal trial

Guideline-oriented Research in the Management of Some Common and Severe Skin Diseases

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12003538
Enrollment
Unknown
Registered
2012-12-27
Start date
2011-08-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bullous pemphigoid

Interventions

Glucocorticoids group:This group receives systemic glucocorticoid, initially, with prednisone at 1mg/kg/day. Then we adjust the dose of glucocorticoid according to the patients' responses

Sponsors

Institute of dermatology, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Above 18 years old,male or female; (2) According with the diagnostic criteria for bullous pemphigoid(erythema and vesicles on skins and/or mucous membranes;dermatopathology shows subepidermal bulla;direct or indirect immunofluorescence (DIF/IIF) staining reveals IgG and/or C3 deposited as linear-pattern along the basement membrane zone;BP180 ELISA positive); (3) Clinical severity rating>1(scoring criteria refers to Appendix 13); (4) Subjects completely understand the trial and voluntarily sign the informed consent

Exclusion criteria

Exclusion criteria: (1) Regimen or dose of treatment for bullous pemphigoid have changed within one month; (2) Subjects who have severe local or systemic acute or chronic infection which is difficult to control and may affect the efficacy of the drugs or the clinical evaluation; (3) Subjects who have severe heart, lung, liver (ALT/AST>=1.5×ULN), kidney or other severe diseases; (4) Pregnant and lactating female or subjects who have fertility plan recently; (5) With a history of malignant tumor; (6) Subjects who are allergic to the test drugs or have contraindications; (7) With other skin diseases that may affect the clinical evaluation; (8) Other conditions which researchers consider the subjects not compatible to the trial.

Design outcomes

Primary

MeasureTime frame
Pemphigoid antibodies titer;Date of stopping blisterring;Date of erosion surface completely drying;

Secondary

MeasureTime frame
Glucocorticoid dosage;Electrocardiogram;Chest X-ray/CT;

Countries

China

Contacts

Public ContactBaoxi Wang

Institute of dermatology, Chinese Academy of Medical Sciences

wangbx@ncstdlc.org+86 028-85478071

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026