Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid (ARABUL)

December 3, 2008 updated by: University Hospital, Limoges

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87042
        • Recruiting
        • Limoges University hospital
        • Contact:
        • Sub-Investigator:
          • Agnès SPARSA, MD
        • Sub-Investigator:
          • Jean Marie BONNETBLANC, MD
        • Sub-Investigator:
          • Julie CENDRAS, MD
      • Pessac, France, 33604
        • Not yet recruiting
        • Bordeaux University Hospital
        • Contact:
          • Marie Sylvie DOUTRE, MD
          • Phone Number: 0557656432
        • Principal Investigator:
          • Marie Sylvie DOUTRE, MD
      • Toulouse, France, 31059
        • Not yet recruiting
        • Toulouse University Hospital
        • Contact:
          • Carle PAUL, MD
          • Phone Number: 0561777675
        • Principal Investigator:
          • Carle PAUL, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Investigators

  • Principal Investigator: Christophe BEDANE, MD, University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Registration Dates

First Submitted

December 3, 2008

First Submitted That Met QC Criteria

December 3, 2008

First Posted (ESTIMATE)

December 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2008

Last Update Submitted That Met QC Criteria

December 3, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-003545-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe