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:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT05514834
Eligibility Criteria:
Inclusion Criteria:
* Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPPA Authorization
* Healthy men and women, ages 30 - 65 years of age
* Subjects with Fitzpatrick photo skin type I-VI
* Subjects with moderate to severe nasolabial folds contour deficiencies or other facial wrinkles. Degree of nasolabial folds or other facial wrinkles will be determined on the basis of the Wrinkles Severity Rating Scale
* Subjects who agree not to have any other procedures of affecting skin quality (microdermabrasion, peels, acne treatments, toxin, fillers etc.) for the duration of the study
* Subjects who understand the study and are able to follow study instructions and are willing to attend the required study visits.
* Subjects who agree to be photographed for research purposes and their identity may not be concealed in these photographs.
Exclusion Criteria:
* Subjects who have had any kind of aesthetic therapy (peeling, laser, ultrasound, toxins, fillers) in the facial area during the last 6 months
* Presence of implant in the facial area to treat
* Contraindications to the use of antiseptics (Biseptine, Amukine)
* Subjects who have an active or known skin inflammation or infection within the treatment area.
* Subjects who have an active or known acute skin allergies
* Subjects who have a known allergy to hyaluronic acid
* Subjects who have any other dermatologic conditions including acne, rosacea, eczema, psoriasis, actinic keratosis, severe sun damage, infection, or scars within the treatment area.
* Subjects of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy, or bilateral oophorectomy.
* Subjects who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy.
* Subjects who have been diagnosed with diabetes
* Subjects who are Immunosuppressed
* Subjects who are HIV+ / VHB+ / VHC+
* Subjects who have had/will have a COVID vaccine within 2 weeks of study participation
* Subjects who have had/will have a dental procedure within 4 weeks of study participation
* Subjects with a history of severe bee allergy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT05514834
Study Brief:
Protocol Section:
NCT05514834