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
|First Submitted Date ICMJE||December 3, 2008|
|First Posted Date ICMJE||December 4, 2008|
|Last Update Posted Date||December 4, 2008|
|Study Start Date ICMJE||September 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid|
|Official Title ICMJE||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).
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Bullous Pemphigoid|
|Intervention ICMJE||Drug: leflunomide|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||65 Years and older (Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||France|
|Removed Location Countries|
|NCT Number ICMJE||NCT00802243|
|Other Study ID Numbers ICMJE||2007-003545-32|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University Hospital, Limoges|
|Collaborators ICMJE||Not Provided|
|PRS Account||University Hospital, Limoges|
|Verification Date||December 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP