NCT00802243

Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid

Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Bullous Pemphigoid

Interventions

Type	Name	Description
DRUG	leflunomide

Timeline

• Start date: 2007-09-01
• First posted: 2008-12-04
• Last updated: 2008-12-04

Locations

3 sites across 1 country: France