MedTrace Logo

Topical Steroids Alone or Associated With Methotrexate in Bullous Pemphigoid

NCT02313870 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2026-04-24

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Olivier Dereure, MD, PhD · University of Montpellier France; French Society of Dermatology; french group for study of blistering diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-22
Primary Completion
2015-05-26
Completion
2015-12-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02313870 on ClinicalTrials.gov