Clinical trial NCT00247559: Botulinum Type A Toxin in the Treatment of Lateral Canthal Lines (Crow's Feet)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Canthal Lines
Keywords: crow's feet
cosmesis
ageing
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-11-02
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in severity of crow's feet at maximum smile at week 4, compared to baseline, assessed photographically by independent panel
Secondary outcomes:
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
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique Bel Air
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice
city: Saint Cloud
country: France
facility: Service de Chirurgie Maxillo Faciale
city: Berlin
country: Germany
facility: Charite-Universitatsmedizin Berlin
city: Dresden
country: Germany
facility: Dermatologie, Stadt. Klinikum Dresden-Friedrichstadt
city: Homburg
country: Germany
facility: Universitats - Hautklinik
city: Cambridge
country: United Kingdom
facility: The Cambridge Private Hospital
state: England
city: London
country: United Kingdom
facility: Harley Street
state: England
city: Clydebank
country: United Kingdom
facility: The Golden Jubilee National Hospital
state: Scotland
Study officials:
affiliation: Ipsen
name: UK Medical Director
role: STUDY_DIRECTOR
References: