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Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid

NCT ID: NCT00802243

Last Updated: 2008-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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

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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

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Bullous Pemphigoid

Keywords

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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.

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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leflunomide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Principal Investigators

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Christophe BEDANE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

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Limoges University Hospital

Limoges, , France

Site Status RECRUITING

Bordeaux University Hospital

Pessac, , France

Site Status NOT_YET_RECRUITING

Toulouse University Hospital

Toulouse, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Christophe BEDANE, MD

Role: CONTACT

Phone: 0555056430

Email: [email protected]

Facility Contacts

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Christophe BEDANE, MD

Role: primary

Marie Sylvie DOUTRE, MD

Role: primary

Carle PAUL, MD

Role: primary

Other Identifiers

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2007-003545-32

Identifier Type: -

Identifier Source: org_study_id