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

Launched by IPSEN · Nov 1, 2005

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Gender

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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.