Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid

Condition(s) targeted: Bullous Pemphigoid

Intervention: leflunomide (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University Hospital, Limoges

Official(s) and/or principal investigator(s):
Christophe BEDANE, MD, Principal Investigator, Affiliation: University Hospital, Limoges

Overall contact:
Christophe BEDANE, MD, Phone: 0555056430, Email: christophe.bedane@chu-limoges.fr

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.

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

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

Primary outcome:

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:

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.

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).

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Christophe BEDANE, MD, Phone: 0555056430, Email: christophe.bedane@chu-limoges.fr

Limoges University Hospital, Limoges 87042, France; Recruiting
Christophe BEDANE, MD, Phone: 0555056430, Email: christophe.bedane@chu-limoges.fr
Agnès SPARSA, MD, Sub-Investigator
Jean Marie BONNETBLANC, MD, Sub-Investigator
Julie CENDRAS, MD, Sub-Investigator

Bordeaux University Hospital, Pessac 33604, France; Not yet recruiting
Marie Sylvie DOUTRE, MD, Phone: 0557656432
Marie Sylvie DOUTRE, MD, Principal Investigator

Toulouse University Hospital, Toulouse 31059, France; Not yet recruiting
Carle PAUL, MD, Phone: 0561777675
Carle PAUL, MD, Principal Investigator

Starting date: September 2007
Last updated: December 3, 2008