Topical Steroids Alone or Associated With Methotrexate in Bullous Pemphigoid

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This controlled multi-center randomized clinical trial, with direct individual benefit, will compare efficacy and safety of two strategies in non-localized BP care: a combined regimen using initial superpotent topical steroids associated with methotrexate for 4 weeks followed by methotrexate alone for 8 months and superpotent topical steroids alone maintained 9 months (current standard of care). The expected result is an equivalence between the two compared strategies in terms of safety and efficacy, MTX monotherapy during the maintenance phase being easier to manage and therefore associated with better compliance than topical steroids with less cutaneous side effects and most cost-effective.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Treatments: Clobetasol; Methotrexate

Criteria

Inclusion Criteria:

• Subjects aged 18 years old or more

• Patients affiliated to social security system,

• Bullous pemphigoid diagnosed according to the following criteria: presence of at least 3 of the 4 clinical criteria for bullous pemphigoid as published by the french group for study of blistering diseases (positive predictive value: 95 %: age over 70 years, no lesions on neck or head, absence of atrophic scars, no mucosal lesions.= Histological Examination consistent with BP diagnosis and carried out in the month before inclusion: existence of a sub epidermal blister regardless of its size, containing neutrophils and / or eosinophils associated with a dermal infiltrate consisting of neutrophils and / or eosinophils, or to margination of neutrophils and / or eosinophils along the dermoepidermal junction.= Direct immunofluorescence performed (DIF) in the month preceding inclusion and showing linear deposition of IgG and / or C3 along the dermo-epidermal junction.

• Patients: = no prior topical steroid or superpotent topical steroids for less than 16 days using the same or equivalent dosage as the one used in the study a different regimen and this regardless of the clinical resultsOR receiving potent or superpotent topical steroids for at least 16 days with a different regimen than that used during the trial AND not controlled by this treatment (appearance of at least 3 new blisters per day)

• written consent of the patient or, if not possible, certified by a third party,

• effective contraception (oral or intrauterine device) set up at least one month before inclusion for women of childbearing age,

• For women of reproductive age (age <50 years), negative serum pregnancy test at inclusion

• Serum albumin ≥ 25 g / L

Exclusion Criteria:

• Localized bullous pemphigoid (area <400 cm2: 20 x 20 cm)

• Major blood cytopenia: Hb ≤ 10 g / dl and / or leukocytes ≤ 3000 / mm3 and / or platelets ≤ 100,000 / mm3

• Creatinine Clearance appreciated by the formula MDRD <30 ml / min

• Serum albumin <25 g / L

• pregnancy-associated Pemphigoid

• Linear IgA Dermatosis identified by DIF

• Pemphigoid with clinically dominant mucosal lesions

• Relapse of previously diagnosed pemphigoid and still receiving treatment or for whom treatment was stopped for less than six months

• Known allergy to topical steroids and / or methotrexate

• recent history of liver disease (within two years) regardless of its nature or presence of active liver disease (transaminases and / or alkaline phosphatase greater than twice the upper standard laboratory)

• Chronic alcoholism (declared consumption of more than 60 g alcohol / day or approximately 0.5 L / day of wine)

• patient receiving notoriously hepatotoxic drugs or that can interfere with metabolism or haematological toxicity of Methotrexate

• Peptic ulcer proven by endoscopy performed during the last 15 days

• Severe Active infection regardless of its nature

• Evolutive neoplasia whatever its nature except basal cell carcinoma

• Poorly controlled diabetes mellitus (fasting glucose greater than or equal to 2 2.5 g / L and / or Hb A1C greater than or equal to 8.5% before treatment)

• disease that can not be possibly monitored on a regular basis

• acquired or congénital Immunosuppression

• known HIV Seropositivity

• Chronic respiratory failure

• Pregnancy or breastfeeding

• Patient of childbearing age and not using effective contraception

• Patient incapable of giving informed consent and for whom a family member or a trustworthy third party does not grant participation in the study, protected adults, vulnerable people (art. L1121-6, L1121-7, L 1121-8, L1121-9) or patient accrued in another clinical research study

• Long-term treatment prescribed for another illness by steroids, immunosuppressive drugs, cyclosporin or any other treatment that may have been successfully used in the treatment of bullous pemphigoid (dapsone, Gamma globulins, plasma exchange, tetracyclines). For all previous medications, a minimum clearance of two months is required before enrollment in the present trial