Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid (ARABUL)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University Hospital, Limoges.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00802243
First received: December 3, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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 Intervention Phase
Bullous Pemphigoid
Drug: leflunomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 54
Study Start Date: September 2007
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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802243

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

Locations
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
Principal Investigator: Christophe BEDANE, MD University Hospital, Limoges
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00802243     History of Changes
Other Study ID Numbers: 2007-003545-32
Study First Received: December 3, 2008
Last Updated: December 3, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
Pemphigoid, Bullous
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Skin Diseases, Vesiculobullous
Leflunomide
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014