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 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT06871592
Eligibility Criteria:
Inclusion Criteria:
1. Men and women aged between 20 and 60.
2. Subjects who are capable of understanding and comply with the study procedures, instructions, and visit schedule.
3. Subjects who voluntarily decide to participate in the entire course of the trial and provide written consent in the Informed Consent Form.
Exclusion Criteria:
1. Subjects with a history of anaphylaxis, allergy hyaluronic acid products, or any component of devices.
2. Subjects with autoimmune diseases/ received immune system and Subjects with diabetes mellitus.
3. Subjects with a history of a hypertrophic scar.
4. Pregnant or breastfeeding women.
5. Subjects with epilepsy or underlying porphyria.
6. When there is inactive disease (such as inflammation, infection or tumours) in or near the intended treatment site.
7. Treatment procedure (e.g., bioresorbable fillers, laser/light therapies, botulinum toxin A injections, face lift, facial peels, excisional facial surgery, dermal photorejuvenation clinically significant oral or maxillofacial surgery, etc.) that may interfere with the treatment area or evaluation within 6 months prior to screening as determined by the Principal Investigator.
8. The subject who received soft tissue augmentation as following at the investigational medical device injection site within 6 months prior to screening as determined by the Principal Investigator.
9. The subject who received soft tissue augmentation near the injection site with any of the following at any time.
10. Subjects with a scar or skin lesion at the investigational medical device injection site that may interfere with the judgment of the treatment effect.
11. Subjects who participated in another clinical trial within 60 days prior to screening or plan to participate in another investigation during the course of this study.
12. Subjects who plan to receive other wrinkle improvement treatment in the face during this trial.
13. Subjects who are otherwise determined by the investigator as ineligible for this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT06871592
Study Brief:
Protocol Section:
NCT06871592