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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT02128204
Eligibility Criteria:
Inclusion Criteria:
* Be 25 to 60 years of age and of any sex who is willing to receive nasolabial folds correction by intradermal injection procedures
* Have approximately symmetrical nasolabial folds with a nasolabial folds severity grade of 2-4 and the grade difference between two sides is less than 1
* Agree to refrain from undergoing invasive aesthetic treatments in the injective areas 12 months after the injections
* Agree to refrain from undergoing other physical or chemical aesthetic treatments in the injective areas 3 months after the injections
* If female of child-bearing potential, not be breastfeeding, have a negative urine pregnancy test on the treatment day and agree to use any approved contraceptives or medically acceptable method of birth control throughout the study
* Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures
Exclusion Criteria:
* Have history or active dermal diseases, inflammation, or any related disease
* Had permanent or semi-permanent implantation on nasolabial areas
* Had invasive aesthetic treatments or surgeries history 6 months before the treatments
* Had physical or chemical aesthetic treatments 1 months before the study starts
* Have history of coagulation defect diseases and still take aspirin, anticlotting, or blood activating medications 1 week before the treatments
* Have Adams-Stokes syndromes, wolff-prkinson-white syndromes, severe sinus node, the atrioventricular node dysfunction, or the blocked ventricular
* Have a known history of allergic reactions like hypersensitivity to hyaluronic acid
* Have a known history of allergic reactions like hypersensitivity to lidocaine or other anaesthetics
* Have poor compliance with the study or follow-up schedule
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
60 Years
Study:
NCT02128204
Study Brief:
Protocol Section:
NCT02128204