Bullous Pemphigoid Clinical Trial
Official title:
Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective Study
Bullous pemphigoid (BP) is the most common blistering auto-immune disease of skin with an
incidence estimated to 400 new cases per year. Topical corticosteroid therapy is considered
the standard treatment for bullous pemphigoïd in 2002. Topical corticosteroid requires an
initial large hospitalization during the acute phase and rehospitalization during relapse.
The usefulness of immunosuppressive drugs have suggested by uncontrolled study.
In this way, leflunomide could be an alternative therapy, and to reduce relapse and/or
resistance risks.
This study could prove the efficacity of leflunomide, associated with short time topical
corticosteroids.
Pre-inclusion stage: Case history, clinical examination, laboratory study, inclusion
criteria checking.
Inclusion stage: Inclusion and exclusion criteria checking, clinical examination, disease
follow-up, written inform consent.
Ambulatory hospitalisation, laboratory study.
Treatment and follow-up of the patients.
Clobetasol propionate cream application and leflunomide introduction.
After inclusion, the treatment will begin with 40 g topical corticosteroid per day and 20 mg
leflunomide per day.
Topical corticosteroids will be progressively decreased during 5 months and stopped.
Follow-up: monthly during one year in the department of dermatology, university hospital
(clinical examination, laboratory study).
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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