NCT00247559

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2004

Shorter than P25 for phase_2

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2005

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

November 1, 2005

Last Update Submit

November 21, 2019

Conditions

Lateral Canthal Lines

Keywords

crow's feetcosmesisageing

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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

Interventions

Botulinum toxin type ABIOLOGICAL
Also known as: AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Clinique Bel Air

Bordeaux, 33200, France

Location

Centre Hospitalier Universitaire de Nice

Nice, 06002, France

Location

Service de Chirurgie Maxillo Faciale

Saint-Cloud, 92211, France

Location

Charite-Universitatsmedizin Berlin

Berlin, 10117, Germany

Location

Dermatologie, Stadt. Klinikum Dresden-Friedrichstadt

Dresden, 01067, Germany

Location

Universitats - Hautklinik

Homburg, 66421, Germany

Location

The Cambridge Private Hospital

Cambridge, England, SG8 5QD, United Kingdom

Location

Harley Street

London, England, W1G 7LE, United Kingdom

Location

The Golden Jubilee National Hospital

Clydebank, Scotland, G81 4HX, United Kingdom

Location

MeSH Terms

Interventions

Botulinum Toxins, Type AabobotulinumtoxinA

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • UK Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2005

First Posted

November 2, 2005

Study Start

May 1, 2004

Primary Completion

April 8, 2005

Study Completion

April 8, 2005

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations

FR(3)DE(3)GB(3)