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Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid

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Disease Information

Descriptive Information
Brief Title † Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid
Official Title † Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective Study
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.
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 Phase Phase 2
Study Type † Interventional
Study Design † Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Stage 1 : complete clinical remission after 6 months treatment for 9 patients at least among 15 appraisable patients.
Secondary Outcome Measure † To determine the rate of clinical complete remission at M9 and M12.
Condition † Bullous Pemphigoid
Intervention † Drugleflunomide
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 54
Start Date † September 2007
Completion Date
Primary Completion Date
Eligibility 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
Gender Both
Ages 65 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Christophe BEDANE, MD, 0555056430, christophe.bedane@chu-limoges.fr
Location Countries † France
Administrative Information
NCT ID † NCT00802243
Organization ID 2007-003545-32
Secondary IDs ††
Responsible Party
Study Sponsor † University Hospital, Limoges
Collaborators ††
Investigators † Principal Investigator: Christophe BEDANE, MD, University Hospital, Limoges
Information Provided By
Verification Date December 2008
First Received Date † December 3, 2008
Last Updated Date December 3, 2008
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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