Clinical Trial: Topical Steroids Alone or Associated With Methotrexate in Bullous Pemphigoid
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Comparison of Monotherapy With Protracted Superpotent Topical Steroids to Superpotent Topical Steroids Associated With Methotrexate in Bullous Pemphigoid
Brief 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.
Detailed Summary: Bullous pemphigoid (BP) is a rare mucocutaneous autoimmune bullous disorder (incidence <1/10000 / year in France) that mostly affects elderly patients. Its mortality rate is as high as 20 to 40% at one year. A study initiated by the French group for bulllous disorders devoted to the study of autoimmune bullous diseases the study of autoimmune bullous diseases and which is an international leader on this issue, has previously demonstrated the efficacy and relatively good tolerance of superpotent topical corticosteroids in BP.However, the use of superpotent topical corticosteroids is flawed with practical difficulties (home-based care by nurses once or twice a day to administer treatment, this for several months) and its cost is significantly higher than that an oral steroid treatment as a consequence. On the other hand, there is probably a non-negligible systemic absorption of superpotent topicalsteroid responsible for potentially serious side effects similar to those encountered with systemic corticosteroids. Finally, a protracted treatment with superpotent topical steroid most often causes skin atrophy with deleterious consequences.It would then be of interest to be able to significantly reduce the duration of use of topical steroids through an early-associated systemic treatment relying on an easy-to-use and relatively safe molecule that would maintain the disease under control after an initial clinical remission has been achieved by initial and time-limited use of superpotent topical steroids. Methotrexate (MTX) could be an interesting candidate in this regard, with a low-level and tolerable short- and middle-term toxicity if small doses are used (10-15 mg / week) while its long-term safety is usually irrelevant in elderly patients. Its use and monitoring are relatively easy and a number of international publications, including two recent French ones, have shown efficacy in this setting including a relaying strategy after initial use of superpotent topical ste
Sponsor: University Hospital, Montpellier
Current Primary Outcome: actuarial survival [ Time Frame: 9 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Initial control rate of the disease [ Time Frame: 9 months ]The initial control rate of the disease at D28 (Visit 4)
- Safety: The frequency of serious and significant adverse events [ Time Frame: 9 months ]
- Frequency of relapses [ Time Frame: 9 months ]The frequency of relapses during treatment
- Relapse-free survival [ Time Frame: 9 months ]relapse-free survival
- Easiness of use [ Time Frame: 9 months ]Easiness of use indirectly estimated by treatment complicance evaluation
Original Secondary Outcome: Same as current
Information By: University Hospital, Montpellier
Dates:
Date Received: December 8, 2014
Date Started: January 2008
Date Completion: December 2015
Last Updated: December 11, 2014
Last Verified: December 2014
