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Use of Tripterygium glycosides and Nicotinamide plus Minocycline 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-12003592
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

Tripterygium glycosides group:Take tripterygium glycosides orally at 20 mg, 3 times a day
Nicotinamide plus Minocycline group:Take nicotinamide at 500 mg, 3 times a day and minocycline 100 mg, twice a day.

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
Number of new blister/blood blister within 24 hour;Erythema, blister, erosion accounts for the total;Mucosal damage and parts;New blister stopping time;Erosion surface completely drying time;Blister completely resolving time;Curative effect improving percentage;Weight;Vital signs;Blood Tests;Urine-routine;Bullous pemphigoid antibodies titer;

Secondary

MeasureTime frame
Menstrual situation;Illness grading score;Electrocardiogram;HBsAg, HCV, HIV;

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