Systemic Sclerosis Patients With Digital Ulcers Clinical Trial
Trial to Confirm the Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic Sclerosis
Efficacy and safety of local infusion of botulinum toxin type B in patients with systemic sclerosis (SSc) with digital ulcer is evaluated by a randomized, double-blind study.
To assess the efficacy and safety of local injection of botulinum toxin type B (BTX-B)
against digital ulcers (DUs) and Raynaud's phenomenon (RP) in patients with systemic
In a randomized, double-blind, placebo-controlled, investigator-initiated clinical trial (phase II), 10 patients with SSc and RP-related DUs were randomly and evenly assigned to a placebo control group or treatment group taking BTX-B injections. The degree of improvement in DU, change in size, number of new DUs, improvement in symptoms of RP, and adverse events were recorded. ;
|Start date||December 12, 2016|
|Completion date||May 14, 2019|