Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT00247559
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00247559
Study Brief:
Protocol Section:
NCT00247559