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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT02019004
Eligibility Criteria:
Inclusion Criteria:
1. Females and males
2. In good health
3. Is 20-65 years of age
4. Has static and moderate dynamic forehead/glabellar wrinkles
5. Has willingness and the ability to understand and provide informed consent and communicate with the study staff
Exclusion Criteria:
1. Pregnant or lactating
2. Younger than 20 or older than 65 years of age
3. Has received the following treatments in the forehead or glabellar region:
1. botulinum toxin injections in the past 6 months
2. ablative laser procedure in the past 6 months
3. radiofrequency device treatment in the past 6 months
4. ultrasound device treatment in the past 6 months
5. medium to deep chemical peel in the past 6 months
6. temporary soft tissue augmentation material in the area to be treated in the past year
7. semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years
8. permanent soft tissue augmentation material in the area to be treated
4. Is planning to receive within the next 6 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region.
5. Is planning to use tretinoin or retinoic acid in the next 6 months
6. Has an active infection in the forehead or glabellar region (excluding mild acne)
7. Is allergic to cow's milk protein
8. Is allergic to albumin
9. Taking aminoglycoside
10. Is currently using anticoagulation therapy
11. Has a history of bleeding disorders
12. Has a mental illness
13. Unable to understand the protocol or to give informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT02019004
Study Brief:
Protocol Section:
NCT02019004