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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07398768
Eligibility Criteria:
Inclusion Criteria:
1. 18 years or older at time of treatment.
2. At least mild static perioral lines and maximum of thin lips, as assessed by the investigator.
3. Participant has a stable medical condition with no uncontrolled systemic disease.
4. Willingness to participate in the routine follow-up after 12 weeks and a signed ICF.
5. Participant already visiting the clinic for the specific treatment.
Exclusion Criteria:
1. Pregnancy and breast feeding.
2. Known impairment of blood coagulation.
3. Presence of acute infection or inflammation at the proposed injection sites.
4. Hyaluronic Acid-Filler treatment in the perioral area within the last 6 months.
5. Patients with a history of autoimmune disease or who are receiving immune therapy.
6. History of hypersensitivity to hyaluronic acid, lidocaine hydrochloride or other amidetype local anaesthetics.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07398768
Study Brief:
Protocol Section:
NCT07398768