Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid

Phase 2

• Conditions: Bullous Pemphigoid

• Registration Number: NCT00802243
• Lead Sponsor: University Hospital, Limoges

Brief 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).

Study Timeline

• Study Start: 2007-09
• Status Verified: 2008-12
• Study First Submitted: 2008-12-03
• Study First Submitted QC: 2008-12-03
• Last Update Submitted: 2008-12-03
• Study First Posted: 2008-12-04
• Last Update Posted: 2008-12-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Bordeaux University Hospital; 🇫🇷 Pessac, France

Toulouse University Hospital; 🇫🇷 Toulouse, France

Limoges University Hospital; 🇫🇷 Limoges, France