Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid (ARABUL)
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| ClinicalTrials.gov Identifier: NCT00802243 |
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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
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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 |
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 (Clinical Trial) |
| Estimated Enrollment : | 54 participants |
| 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 |
- 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.
- 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.
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult ≥ 65 years old
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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:
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
| Contact: Christophe BEDANE, MD | 0555056430 | christophe.bedane@chu-limoges.fr |
| 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 | |
| Principal Investigator: | Christophe BEDANE, MD | University Hospital, Limoges |
| ClinicalTrials.gov Identifier: | NCT00802243 History of Changes |
| 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:
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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 Antirheumatic Agents |