Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid (ARABUL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00802243
Recruitment Status : Unknown
Verified December 2008 by University Hospital, Limoges.
Recruitment status was:  Recruiting
First Posted : December 4, 2008
Last Update Posted : December 4, 2008
Information provided by:
University Hospital, Limoges

December 3, 2008
December 4, 2008
December 4, 2008
September 2007
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  • 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.
Same as current
No Changes Posted
  • 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.
Same as current
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Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid
Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective Study

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.

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).

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bullous Pemphigoid
Drug: leflunomide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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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:

Sexes Eligible for Study: All
65 Years and older   (Older Adult)
Contact information is only displayed when the study is recruiting subjects
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University Hospital, Limoges
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Principal Investigator: Christophe BEDANE, MD University Hospital, Limoges
University Hospital, Limoges
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP