Clinical trial NCT00802243: Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid
Official title: Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bullous Pemphigoid
Keywords: Bullous pemphigoid
leflunomide
corticosteroid treatment reduction
Patients are screened by: the physicians in different departments of the hospital, the liberal dermatologists and the general practicioners.
Phase I: Patients will be referred to the investigators of Dupuytren Hospital Dermatology Department.
Phase II: Patients will be referred to the investigators of Purpan (Toulouse), Haut Leveque (Pessac) and Dupuytren (Limoges) Hospitals.
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2008-12-04
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Stage 1 : complete clinical remission after 6 months treatment for 9 patients at least among 15 appraisable patients.
measure: Stage 2 : complete clinical remission after 6 months treatment for 27 patients at least among 43 appraisable patients.
Secondary outcomes:
measure: To determine the rate of clinical complete remission at M9 and M12.
measure: To estimate the number of patients with immunological remission at M6, M9 and M12.
measure: To evaluate monthly the tolerance of leflunomide.
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges University Hospital
city: Pessac
country: France
facility: Bordeaux University Hospital
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
affiliation: University Hospital, Limoges
name: Christophe BEDANE, MD
role: PRINCIPAL_INVESTIGATOR
References: