Trial intelligence / Profile preview

Field Effects of Dysport vs Botox in Forehead Wrinkles

NCT00989768Phase 4

Key facts

Status
Completed
Start
May 2005
Primary completion
Nov 2007
Countries
1
Modality
Recombinant Proteins and Enzymes
Conditions
forehead wrinkles
01

Overview

Phase 4, randomised, double-blind trial of botulinum toxin type A in forehead wrinkles, sponsored by Hexsel Dermatology Clinic. Primary endpoint: Horizontal Action Halo Diameter at 112 days. Started May 2005; status: completed.

02

Design

1 arm
Study design
RandomizedDouble-blind
  • Split-face Dysport vs Botox

    Patients receive Dysport on one side of the forehead and Botox on the other.

03

Who it enrols

Adult females with moderate to severe forehead wrinkles and a positive Minor's test for sweating, excluding those with prior recent botulinum toxin treatment or neuromuscular diseases.

04

Endpoints

Primary

  • Horizontal Action Halo Diameter

Secondary

  • Compound Muscle Action Potential in m. Frontalis

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