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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT03166618
Eligibility Criteria:
Inclusion Criteria:
-Has temple hollowing and is seeking restoration in the temple area.
Exclusion Criteria:
* Has temple hollowing due to due to trauma, congenital malformations, or lipodystrophy
* Has received permanent facial implants in the face or neck
* Has undergone fat injections
* Has tattoos, piercings, facial hair or scars that would interfere with visual assessment of the temple
* Has undergone semipermanent dermal filler treatment in the temple or mid-face within the past 36 months
* Has undergone dermal filler injections above the subnasale within the past 24 months
* Has temporal arteritis or history of temporal arteritis
* Has temporomandibular joint dysfunction
* Has eye inflammation or infection
* Has a history of detached retina, retinal vascular occlusion, narrow angle glaucoma, or neovascular eye disease
* Has ever received a facelift, browlift, or facial reconstructive surgery
* Has undergone mesotherapy or cosmetic treatment (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck or botulinum toxin injections within the past 6 months
* Has experienced trauma to the temple within the past 6 months or has residual deficiencies, deformities, or scarring
* Has a tendency to develop hypertrophic scarring
* Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein
* Has porphyria or untreated epilepsy
* Has active autoimmune disease
* Has current cutaneous or mucosal inflammatory or infectious processes
* Is on a lidocaine, anticoagulation therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT03166618
Study Brief:
Protocol Section:
NCT03166618