Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid

NCT00802243 | Unknown Phase 2 DMC

• 1 other identifier: 2007-003545-32
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

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.

Conditions

Bullous Pemphigoid

Keywords

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.

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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.

Interventions

leflunomide DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (3)

Limoges University Hospital

Limoges, 87042, France

RECRUITING

Bordeaux University Hospital

Pessac, 33604, France

NOT YET RECRUITING

Toulouse University Hospital

Toulouse, 31059, France

NOT YET RECRUITING

MeSH Terms

Conditions

Pemphigoid, Bullous

Interventions

Leflunomide

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christophe BEDANE, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe BEDANE, MD

CONTACT

0555056430; christophe.bedane@chu-limoges.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 3, 2008
• First Posted: December 4, 2008
• Study Start: September 1, 2007
• Last Updated: December 4, 2008

Record last verified: 2008-12

Locations

FR (3)