At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double Blinded Randomized Controlled Trial to Compare the Efficacy, Time to Onset, and Duration of Two Botulinum Type A Exotoxins (Onabotulinum Toxin A and Abobotulinum Toxin A) in the Treatment of "Crow's Feet."
In Brief
A Phase 4 clinical trial evaluating Right lateral orbital injection of Botox Cosmetic or Dysport and Left lateral orbital injection of Botox Cosmetic or Dysport for Intrinsic Aging of Skin and Solar Elastosis. Completed, enrolled 90 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Right lateral orbital injection of Botox Cosmetic or Dysport (10 units and 30 units, respectively) divided among 4 injection points (0.05 mL \[7.5 units\] per injection point) divided among 4 injection points (0.05mL \[2.5units\]) on Day 0 of the study
Left lateral orbital injection of Botox Cosmetic or Dysport (10 units and 30 units, respectively) divided among 4 injection points (0.05 mL \[7.5 units\] per injection point) divided among 4 injection points (0.05mL \[2.5units\]) on Day 0 of the study