CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 90 enrolled
Drug / intervention
Right lateral orbital injection of Botox Cosmetic or Dysport +1 moredrug
Likely dose
Right lateral orbital injection of Botox Cosmetic or Dysport 10 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01529788
NCT01529788Phase 4Completed

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."

The Maas Clinic·interventional·Posted Feb 9, 2012·Updated Sep 30, 2014

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 9, 2012
Enrollment StartSep 1, 2009
Primary CompletionSep 1, 2012
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 14.4 years ago

Interventions

Right lateral orbital injection of Botox Cosmetic or Dysportdrug

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 Dysportdrug

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