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 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT05454033
Eligibility Criteria:
Inclusion Criteria:
* Has moderate or severe perioral lines (Perioral Lines at Rest Severity Scale \[POLSS\] Grades 2 or 3) as assessed by the Evaluating Investigator (EI).
* Participants seeking improvement of lines, hydration, and skin smoothness in perioral area.
* Is able to achieve a 1-point improvement in POLSS score in the judgment of Treating Investigator (TI).
* Participant must be in good health as determined by medical history, vital signs, and TI's judgment, including no known active pandemic infection.
Exclusion Criteria:
* Has a history of anaphylaxis, atopy, or allergy to lidocaine, hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study.
* Has current cutaneous inflammatory or infectious processes (e.g., acne, herpes), abscess, an unhealed wound, angioneurotic edema, cheilitis, or a cancerous or precancerous lesion in the perioral area that could interfere with effectiveness assessments.
* Has a tendency to develop hypertrophic scarring.
* Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction.
* Has a history of anaphylactic shock.
* Have a history of or currently suffer from autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease) other than Hashimoto's thyroiditis.
* Has porphyria.
* Has a history of skin cancer.
* Has ever received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) below the subnasale.
* Has ever undergone fat injections or calcium hydroxyapatite below the subnasale.
* Has undergone volume augmentation with semi-permanent soft tissue fillers (e.g., poly-L-lactic acid) within 24 months or temporary soft tissue fillers within 12 months below the subnasale.
* Has undergone treatment with botulinum toxins below the subnasale within 6 months of study entry or is planning to undergo such treatment during the study.
* Has received cosmetic resurfacing below the subnasale within 6 months before enrollment (examples include laser, radiofrequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures) or is planning to undergo such treatment during the study.
* Has received mesotherapy or cosmetic treatments below the subnasale within 3 months before enrollment (e.g., photomodulation, intense pulsed light) or is planning to undergo such treatment during the study.
* Has undergone oral surgery (e.g., tooth extraction, aesthetic restoration of front teeth, or implantation in anterior region) within 30 days before enrollment or is planning to undergo any of these procedures during the study.
* Is undergoing orthodontia before enrollment or is planning to undergo it during the study.
* Has changes in use of over-the-counter or prescription oral anti-wrinkle products or topical products below the subnasale within 30 days before enrollment (participants are not eligible for this study if they have begun using any new over-the-counter or prescription oral or topical, anti-wrinkle products below the subnasale within 30 days before enrollment. Participants who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study).
* Is on a regimen of anti-coagulation therapy (e.g., warfarin, clopidogrel).
* Is on an ongoing regimen of medications (e.g., aspirin, ibuprofen) or other substances (e.g., herbal supplements with garlic, gingko biloba, or ginseng) known to increase coagulation time within 10 days of undergoing study device injection (study device injection may be delayed as necessary to accommodate this 10-day washout period).
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
* Has tattoos, piercings, or scars that would interfere with visual assessment of the perioral lines.
* At TI's discretion, based on participant's safety and/or study integrity, the participant has a condition or is in a situation that, in the TI's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study, such as clinically significant abnormal lab testing results as judged by TI.
* Directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator, study coordinator, or other study staff member; employee of the sponsor; first-degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in the study; or enrolled in the study at another clinical site.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05454033
Study Brief:
Protocol Section:
NCT05454033