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

Lateral Canthal Lines Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247559
• Other study ID #: Y-97-52120-723
• Secondary ID: 2004-001421-17
• Status: Completed
• Phase: Phase 2
• Start date: May 2004
• Est. completion date: April 8, 2005

Study information

• Verified date: November 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: April 8, 2005
• Est. primary completion date: April 8, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lateral Canthal Lines

Intervention

Biological:
• Botulinum toxin type A

Locations

Country	Name	City	State
France	Clinique Bel Air	Bordeaux
France	Centre Hospitalier Universitaire de Nice	Nice
France	Service de Chirurgie Maxillo Faciale	Saint Cloud
Germany	Charite-Universitatsmedizin Berlin	Berlin
Germany	Dermatologie, Stadt. Klinikum Dresden-Friedrichstadt	Dresden
Germany	Universitats - Hautklinik	Homburg
United Kingdom	The Cambridge Private Hospital	Cambridge	England
United Kingdom	The Golden Jubilee National Hospital	Clydebank	Scotland
United Kingdom	Harley Street	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in severity of crow's feet at maximum smile at week 4, compared to baseline, assessed photographically by independent panel
Secondary	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