Onabotulinum Toxin Type A and Abobotulinum Toxin Type A Crow's Feet Rhytid Study
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
The objective of the study is to compare the time to onset of Dysport® versus Botox® in the
treatment of lateral orbital rhytids ("crow's feet"). Thirty subjects were enrolled in the
study; specifically 30 male or female patients 18 years or older with moderate to severe
lateral orbital rhytids at maximum contracture. Each patient were randomized to be treated
with Dysport® on one side and Botox® on the other side. Both the injector and patient were
blinded to the injected toxin.
The efficacy endpoints were determined by investigator and subject live assessment of "crow's
feet" at rest and maximum contraction at each visit (every other day for 6 days
post-injection, every month for 9 months following) using a validated 5 point photographic
scale(no wrinkles [0], very fine wrinkles [1], fine wrinkles [2], moderate wrinkles [3] or
severe wrinkles [4]) used in previous studies. A written description of each photograph was
included to help standardize the application of the Photographic Scale.
Phase:
Phase 4
Details
Lead Sponsor:
The Maas Clinic
Collaborator:
Medicis Pharmaceutical Corporation
Treatments:
abobotulinumtoxinA Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA