Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid (ARABUL)
Recruitment status was: Recruiting
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective Study|
- Stage 1 : complete clinical remission after 6 months treatment for 9 patients at least among 15 appraisable patients.
- Stage 2 : complete clinical remission after 6 months treatment for 27 patients at least among 43 appraisable patients.
- To determine the rate of clinical complete remission at M9 and M12.
- To estimate the number of patients with immunological remission at M6, M9 and M12.
- To evaluate monthly the tolerance of leflunomide.
|Study Start Date:||September 2007|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802243
|Limoges University Hospital|
|Limoges, France, 87042|
|Bordeaux University Hospital|
|Pessac, France, 33604|
|Toulouse University Hospital|
|Toulouse, France, 31059|
|Principal Investigator:||Christophe BEDANE, MD||University Hospital, Limoges|