Bullous pemphigoid (BP) is a chronic, inflammatory, subepidermal, autoimmune blistering disease which mainly develops in the elderly, with onset usually in the late 70s and a substantial increase in incidence in people older than 80 years. If untreated, it can persist for months or years, with periods of spontaneous remissions and exacerbations. It has been found that blisters and sera of BP patients contain abnormally high levels of pro-inflammatory cytokines such as interleukin-6 (IL-6) and IL-8. Recently, it also has been demonstrated that NLRP3 (NACHT, LRR and PYD domains-containing protein 3) inflammasome components (the NLRP3-caspase-1-IL-18 axis) were significantly up-regulated in peripheral blood mononuclear cells from BP patients and positively correlated with disease activity. AC-203 is a topical formulation of an oral modulator of inflammasome and IL-1beta pathways. In vitro studies have demonstrated that AC-203 significantly reduced secretion of IL-6 and moderately reduced IL-8 secretion in HaCaT cells treated with specific anti-BP180 IgG. This study is designed to test the safety, tolerability, efficacy, and pharmacokinetics of AC-203 ointment (vs. a topical steroid comparator representing standard of care) ointment in subjects with BP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
AC-203 1% ointment BID (twice daily)
Clobetasol 0.05% Topical Ointment BID
National Taiwan University Hospital
Taipei, Taiwan
Incidence of adverse events during the treatment period
Time frame: 10 Weeks
Proportion achieving disease control (no new blisters within prior week)
Time frame: 2, 4, 5, 6, 8, 10 Weeks
New blister count
Time frame: 2, 4, 5, 6, 8, 10 Weeks
Time to disease control
Time frame: 2, 4, 5, 6, 8, 10 Weeks
Proportion of subjects who require rescue therapy prior to Week 6
Time frame: 2, 4, 5, 6 Weeks
BPDAI (BP Disease Area Index) score
Time frame: 2, 4, 5, 6, 8, 10 Weeks
Pruritus VAS (Visual Analogue Scale) score change from baseline
Time frame: 2, 4, 5, 6, 8, 10 Weeks
DLQI (Dermatology Life Quality Index) score change from baseline
Time frame: 6, 10 Weeks
Inflammation marker
Time frame: 6 Weeks
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