Topical Steroids Alone or Associated With Methotrexate in Bullous Pemphigoid

PHASE3CompletedINTERVENTIONAL
Enrollment

322

Participants

Timeline

Start Date

January 22, 2008

Primary Completion Date

May 26, 2015

Study Completion Date

December 31, 2015

Conditions
Bullous Pemphigoid
Interventions
DRUG

clobetasol propionate + Methotrexate

daily applications of topical clobetasol propionate at a dose of 10 to 30 g / day depending on the patient's weight and the initial number of new blisters per day, associated with methotrexate (MTX) received either orally or subcutaneously at a dose of 12.5 mg / week in patients weighing less than 60 kg and with creatinine clearance greater than 50 ml / min (planned dose reduction to 10 mg / week in patients less than 60 kg or with a creatinine clearance less than 50 ml / min) for four weeks followed by oral or subcutaneous methotrexate alone at the same dose during following 8 months

DRUG

clobetasol propionate alone

daily applications of topical clobetasol propionate at a dose of 10 to 30 g / day depending on the patient's weight and the initial number of new blisters per day, up to 14 days after control of the disease followed by 1 application every 2 days at the same dose for 4 weeks then an application twice a week for 4 weeks then once application a week until the end of the 9th month of treatment

Trial Locations (1)

34295

University Hospital Of Montpellier, Montpellier

All Listed Sponsors
lead

University Hospital, Montpellier

OTHER

NCT02313870 - Topical Steroids Alone or Associated With Methotrexate in Bullous Pemphigoid | Biotech Hunter | Biotech Hunter