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

Phase 2

Completed

• Conditions: Lateral Canthal Lines

• Registration Number: NCT00247559
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2005-04-08
• Study Completion: 2005-04-08
• Study First Submitted: 2005-11-01
• Study First Submitted QC: 2005-11-01
• Study First Posted: 2005-11-02
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

The Cambridge Private Hospital; 🇬🇧 Cambridge, England, United Kingdom

Harley Street; 🇬🇧 London, England, United Kingdom

Universitats - Hautklinik; 🇩🇪 Homburg, Germany

Clinique Bel Air; 🇫🇷 Bordeaux, France

Centre Hospitalier Universitaire de Nice; 🇫🇷 Nice, France

Service de Chirurgie Maxillo Faciale; 🇫🇷 Saint Cloud, France

Charite-Universitatsmedizin Berlin; 🇩🇪 Berlin, Germany

Dermatologie, Stadt. Klinikum Dresden-Friedrichstadt; 🇩🇪 Dresden, Germany

The Golden Jubilee National Hospital; 🇬🇧 Clydebank, Scotland, United Kingdom