Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid - Full Text View

Sponsored by:	University Hospital, Limoges
Information provided by:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00802243

Purpose

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	Intervention	Phase
Bullous Pemphigoid	Drug: leflunomide	Phase II

Drug Information available for: Corticosteroids Leflunomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective Study

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:

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:

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.

Estimated Enrollment:	54
Study Start Date:	September 2007

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).

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802243

Contacts

Contact: Christophe BEDANE, MD

0555056430

christophe.bedane@chu-limoges.fr

Locations

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
Toulouse University Hospital	Not yet recruiting
TOULOUSE, France, 31059
Contact: Carle PAUL, MD 0561777675
Principal Investigator: Carle PAUL, MD
Bordeaux University Hospital	Not yet recruiting
PESSAC, France, 33604
Contact: Marie Sylvie DOUTRE, MD 0557656432
Principal Investigator: Marie Sylvie DOUTRE, MD

Sponsors and Collaborators

University Hospital, Limoges

Investigators

Principal Investigator:

Christophe BEDANE, MD

University Hospital, Limoges

More Information

Study ID Numbers:	2007-003545-32
Study First Received:	December 3, 2008
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00802243
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Limoges:

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.

Study placed in the following topic categories:

Pemphigoid, Bullous
Autoimmune Diseases
Skin Diseases, Vesiculobullous

Skin Diseases
Bullous pemphigoid
Leflunomide

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs

Enzyme Inhibitors
Antirheumatic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009