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Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid (ARABUL)

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
University Hospital, Limoges

Study Description
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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.


Condition or disease Intervention/treatment Phase
Bullous Pemphigoid Drug: leflunomide Phase 2

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective Study
Study Start Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus Steroids
Drug Information available for: Leflunomide

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Stage 1 : complete clinical remission after 6 months treatment for 9 patients at least among 15 appraisable patients.
  2. Stage 2 : complete clinical remission after 6 months treatment for 27 patients at least among 43 appraisable patients.

Secondary Outcome Measures :
  1. To determine the rate of clinical complete remission at M9 and M12.
  2. To estimate the number of patients with immunological remission at M6, M9 and M12.
  3. To evaluate monthly the tolerance of leflunomide.

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802243


Contacts
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Contact: Christophe BEDANE, MD 0555056430 christophe.bedane@chu-limoges.fr

Locations
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France
Limoges University Hospital Recruiting
Limoges, France, 87042
Contact: Christophe BEDANE, MD    0555056430    christophe.bedane@chu-limoges.fr   
Sub-Investigator: Agnès SPARSA, MD         
Sub-Investigator: Jean Marie BONNETBLANC, MD         
Sub-Investigator: Julie CENDRAS, MD         
Bordeaux University Hospital Not yet recruiting
Pessac, France, 33604
Contact: Marie Sylvie DOUTRE, MD    0557656432      
Principal Investigator: Marie Sylvie DOUTRE, MD         
Toulouse University Hospital Not yet recruiting
Toulouse, France, 31059
Contact: Carle PAUL, MD    0561777675      
Principal Investigator: Carle PAUL, MD         
Sponsors and Collaborators
University Hospital, Limoges
Investigators
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Principal Investigator: Christophe BEDANE, MD University Hospital, Limoges
More Information
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ClinicalTrials.gov Identifier: NCT00802243    
Other Study ID Numbers: 2007-003545-32
First Posted: December 4, 2008    Key Record Dates
Last Update Posted: December 4, 2008
Last Verified: December 2008
Keywords provided by University Hospital, Limoges:
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.
Additional relevant MeSH terms:
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Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Leflunomide
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs