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 @ 7:54 PM
Ignite Modification Date:
2025-12-24 @ 7:54 PM
NCT ID:
NCT05963204
Eligibility Criteria:
Inclusion Criteria:
* Subjects diagnosed with symmetrical, moderate-to-severe cheek wrinkles on each side of the face as assessed via the Galderma Cheek Wrinkles Scale.
* Subjects with symmetrical, mild-to-severe photodamage at both sides of the midface.
* Subject who in the opinion of the treating investigator would need 2 biostimulator treatments for optimal clinical outcomes.
* Ability of giving consent for participation in the study.
* Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.
Exclusion Criteria:
* Subjects with asymmetrical severity or unidentical cheek wrinkle score between 2 sides of the cheek.
* Asymmetrical severity photodamage score between 2 sides of the midface.
* Subjects with a history of allergy or hypersensitivity to any ingredient of the treatment products.
* Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except lips.
* Previous treatment/procedure in the face in the previous 6 months that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during the study.
* Subjects with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT05963204
Study Brief:
Protocol Section:
NCT05963204