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:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT00884234
Eligibility Criteria:
Inclusion Criteria:
1. Female/male ages 30 to 55
2. Bilateral lateral canthal lines rated as moderate or advanced.
3. Willing to refrain from any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at screening through Week 6.
4. Women of child baring potential must practice and be willing to continue to use an effective method of birth control.
Exclusion Criteria:
1. Muscle weakness or paralysis in the area receiving treatment.
2. Active skin disease or irritation at treatment areas.
3. Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to screening.
4. Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0).
5. Use of topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to screening and continuing through End of Study (Week 6).
6. Any abnormality on the electrocardiogram (ECG) at screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive hear failure.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
55 Years
Study:
NCT00884234
Study Brief:
Protocol Section:
NCT00884234