Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid

Bullous Pemphigoid Clinical Trial

— ARABUL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00802243
• Other study ID #: 2007-003545-32
• Status: Recruiting
• Phase: Phase 2
• First received: December 3, 2008
• Last updated: December 3, 2008
• Start date: September 2007

Study information

• Verified date: December 2008
• Source: University Hospital, Limoges
• Contact: Christophe BEDANE, MD
• Phone: 0555056430
• Email: christophe.bedane[@]chu-limoges.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Adult = 65 years old

• Bullous pemphigoid :

• Newly diagnosed bullous pemphigoid : No treatment or topical corticosteroids therapy for less than one month

• BP diagnosed : Resistance of the BP to the treatment or recurrence 6 months at least after diagnosis

• Follow up monthly during one year accepted

• Written Inform Consent

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bullous Pemphigoid
• Pemphigoid, Bullous

Intervention

Drug:
• leflunomide

Locations

Country	Name	City	State
France	Limoges University Hospital	Limoges
France	Bordeaux University Hospital	Pessac
France	Toulouse University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stage 1 : complete clinical remission after 6 months treatment for 9 patients at least among 15 appraisable patients.
Primary	Stage 2 : complete clinical remission after 6 months treatment for 27 patients at least among 43 appraisable patients.
Secondary	To determine the rate of clinical complete remission at M9 and M12.
Secondary	To estimate the number of patients with immunological remission at M6, M9 and M12.
Secondary	To evaluate monthly the tolerance of leflunomide.