Botulinum Type A Toxin in the Treatment of Lateral Canthal Lines (Crow's Feet)

November 21, 2019 updated by: Ipsen

A Phase II, Multi-Centre, Randomised, Double-blind, Dose-Ranging Study Comparing the Efficacy and Safety of a Single Treatment With 15, 30 or 45 Units (Per Eye) of Dysport to Placebo in the Symptomatic Treatment of Lateral Canthal Lines (Crow's Feet)

Despite the wealth of information in the literature regarding the cosmetic applications of botulinum type A toxin (BoNT-A), and the widespread use of the BoNT-A for cosmetic applications, the number of randomised, controlled clinical trials is small. Much of the published information is based on open-label studies or anecdotal data. Of the robust trial data that is available, the vast majority relates to the treatment of glabellar lines, and there is little data available regarding the use of BoNT-A in lateral canthal lines. This study aims to determine the optimum dose for the use of BoNT-A in this area.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33200
        • Clinique Bel Air
      • Nice, France, 06002
        • Centre Hospitalier Universitaire de Nice
      • Saint Cloud, France, 92211
        • Service de Chirurgie Maxillo Faciale
  • Germany
      • Berlin, Germany, 10117
        • Charite-Universitatsmedizin Berlin
      • Dresden, Germany, 01067
        • Dermatologie, Stadt. Klinikum Dresden-Friedrichstadt
      • Homburg, Germany, 66421
        • Universitats - Hautklinik
  • United Kingdom
    • England
      • Cambridge, England, United Kingdom, SG8 5QD
        • The Cambridge Private Hospital
      • London, England, United Kingdom, W1G 7LE
        • Harley Street
    • Scotland
      • Clydebank, Scotland, United Kingdom, G81 4HX
        • The Golden Jubilee National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients, 18 to 65 years of age.
  • In the opinion of the Investigator moderate to severe lateral canthal lines (crow's feet) during maximum smile on both sides of the face.
  • In the opinion of the Investigator mild to severe lateral canthal lines (crow's feet) at rest on both sides of the face.

Exclusion Criteria:

  • Any prior surgery affecting the orbicularis oculi muscle, prior blepharoplasty or brow lift, or any prior cosmetic procedures or scars that may interfere with the evaluation of the study results.
  • Previous insertion of any non-absorbable material in the periorbital region or facial treatment with augmentation material within 12 months prior to screening.
  • Any prior treatment with botulinum toxin (of any serotype).
  • Previous treatment with lasers for skin resurfacing or treatment with deep chemical peels within 12 months prior to screening.
  • Inability to substantially lessen the lateral canthal lines by physically spreading them apart.
  • Facial conditions that could affect safety or efficacy results such as: active infection or other skin problem in the periorbital area (e.g. acute acne lesions or ulcers); history of facial nerve palsy; marked facial asymmetry; ptosis; excessive dermatochalasis; deep dermal scarring; thick sebaceous skin; photodamage etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in severity of crow's feet at maximum smile at week 4, compared to baseline, assessed photographically by independent panel

Secondary Outcome Measures

Outcome Measure
At week 2,4,8,12,16,20,24, compared to baseline: change in severity of crow's feet at rest & max. smile, assessed by investigator & independent panel (photographically); change in patient satisfaction with appearance of crow's feet & general appearance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Investigators

  • Study Director: UK Medical Director, Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

April 8, 2005

Study Completion (Actual)

April 8, 2005

Study Registration Dates

First Submitted

November 1, 2005

First Submitted That Met QC Criteria

November 1, 2005

First Posted (Estimate)

November 2, 2005

Study Record Updates

Last Update Posted (Actual)

November 22, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Y-97-52120-723
  • 2004-001421-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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