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 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT05316233
Eligibility Criteria:
Inclusion Criteria:
* Participants in general good health as determined by Treating Investigator's judgment, including no known active pandemic infection.
* Participants seeking improvement of transverse neck lines.
* Has moderate or severe transverse neck lines (ATNLS Grade 2 or 3) on EI live assessment.
Exclusion Criteria:
* Neck deformity or significant skin laxity with severe redundant folds.
* Significant skin pigmentation disorders or discoloration in the neck area that would interfere with the visual assessment of the neck area.
* Current cutaneous inflammatory or infectious processes (eg. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the neck.
* Tendency to develop hypertrophic scarring.
* History of thyroid cancer, skin cancer of the neck, radiation of the treatment area, or de novo cancer in the treatment area.
* Permanent soft tissue fillers in the neck area.
* Semi-permanent soft tissue fillers in the neck area within 2 years before enrollment.
* HA fillers or autologous fat in the neck area within 12 months before enrollment.
* Mesotherapy, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, microneedling, laser, or other cosmetic procedures in the neck area within 12 months before enrollment.
* Botulinum toxin in the neck area within 6 months before enrollment.
* Deoxycholic acid injections or cryolipolysis in the submentum area within 6 months before enrollment.
* Neck surgeries and procedures.
* Neck tattoos, piercings, pigmentation, hair, or past trauma that would interfere with the visualization of the neck area for the effectiveness assessments.
* Pregnant, nursing or planning a pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT05316233
Study Brief:
Protocol Section:
NCT05316233