Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic Sclerosis
Status:
Completed
Trial end date:
2020-07-31
Target enrollment:
Participant gender:
Summary
This study aims to assess whether or not a single injection schedule of botulinum toxin A
(BTX-A) in both hands improves Raynaud phenomenon (RP) secondary to systemic sclerosis (SSc)
better than a placebo at 4, 12 and 24 weeks after the treatment.
This study's hypothesis is that the number of RP attacks per week from baseline to 4 weeks
after treatment is significantly lower in the group treated with BTX-A than in the control
group treated by the placebo. Furthermore, BTX-A in both hands is expected to improve both
symptomatic (attack frequency, digital ulcer healing) and functional (pain, hand function,
quality of life) symptoms of RP secondary to SSc more than placebo.
Phase:
Phase 3
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A EMLA Lidocaine Nitrous Oxide onabotulinumtoxinA Pharmaceutical Solutions Prilocaine