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Onabotulinum Toxin Type A and Abobotulinum Toxin Type A Crow's Feet Rhytid Study

NCT01529788 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2014-09-30

No results posted yet for this study

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.

Conditions

  • Intrinsic Aging of Skin
  • Solar Elastosis

Interventions

DRUG

Right lateral orbital injection of Botox Cosmetic or Dysport

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

DRUG

Left lateral orbital injection of Botox Cosmetic or Dysport

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

Sponsors & Collaborators

  • Medicis Pharmaceutical Corporation

    collaborator INDUSTRY

  • The Maas Clinic

    lead OTHER

Principal Investigators

  • Corey S Maas, MD · The Maas Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01529788 on ClinicalTrials.gov