Status:
COMPLETED
Botulinum Type A Toxin in the Treatment of Lateral Canthal Lines (Crow's Feet)
Lead Sponsor:
Ipsen
Conditions:
Lateral Canthal Lines
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2005
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT00247559
Start Date
May 1 2004
End Date
April 8 2005
Last Update
November 22 2019
Active Locations (9)
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1
Clinique Bel Air
Bordeaux, France, 33200
2
Centre Hospitalier Universitaire de Nice
Nice, France, 06002
3
Service de Chirurgie Maxillo Faciale
Saint-Cloud, France, 92211
4
Charite-Universitatsmedizin Berlin
Berlin, Germany, 10117