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Use of Oral 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
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12003593
Enrollment
Unknown
Registered
2012-12-30
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, the number of local vesicles<=10(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;Glucocorticoid dosage;Date of glucocorticoid starting to reduce;Date of erosion surface completely drying;

Secondary

MeasureTime frame
Blood-routine;Urine-routine;Stool routine test;Urine pregnancy test;Electrocardiogram;Chest X-ray/CT;Pemphigoid antibodies titer;

Countries

China

Contacts

Public ContactBAoxi Wang

Institute of dermatology; Chinese Academy of Medical Sciences

wangbx@ncstdlc.org+86 025-85478071

Outcome results

None listed

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