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Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid (ARABUL)

U

University of Limoges (UL)

Status and phase

Unknown
Phase 2

Conditions

Bullous Pemphigoid

Treatments

Drug: leflunomide

Study type

Interventional

Funder types

Other

Identifiers

NCT00802243
2007-003545-32

Details and patient eligibility

About

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.

Full 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).

Enrollment

54 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

3

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Central trial contact

Christophe BEDANE, MD

Data sourced from clinicaltrials.gov

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