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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT05741034
Eligibility Criteria:
Inclusion Criteria:
* Participants in general good health as determined by Treating Investigator's (TI) judgment, including no known active pandemic infection.
* Participants seeking improvement of transverse neck lines and hydration in neck area.
* Has moderate or severe transverse neck lines (ATNLS Grade 2 or 3) on EI live assessment.
* The participant is able to achieve at least a 1-point improvement in Allergan Transverse Neck Lines Scale (ATNLS) score with the allowed injection volume in the judgment of TI.
Exclusion Criteria:
* Neck deformity or significant skin laxity with severe redundant folds.
* History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA (hyaluronic acid) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study.
* Have a history of or currently suffer from autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease).
* Current cutaneous inflammatory or infectious processes (e.g., acne, herpes, dermatitis), abscess, an unhealed wound, or a cancerous or precancerous lesion on skin of the neck.
* History of thyroid cancer, thyroid-related diseases, skin cancer of the neck, radiation of the treatment area, or de novo cancer in the treatment area.
* Tendency to develop hypertrophic scarring.
* Has ever received permanent soft tissue fillers (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene), calcium hydroxyapatite filler, or autologous fat in the neck area.
* Has undergone neck surgery.
* Semi-permanent soft tissue fillers (e.g., poly-L-lactic acid, polycaprolactone) in the neck area within 2 years before enrollment.
* Botulinum toxin in the neck area within 6 months before enrollment.
* Neck tattoos, piercings, pigmentation, hair, or past trauma that would interfere with the visualization of the neck area for the effectiveness assessments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05741034
Study Brief:
Protocol Section:
NCT05741034