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:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT02437903
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to read and sign the informed consent and other study documents.
* Treating investigator's score of 3, 4, or 5 on the Temporal Fossa Rating Scale.
* Written informed consent has been obtained prior to any study-related procedures.
* Written Authorization for Use and Release of Health and Research Study Information has been signed.
* Ability to follow study instructions and complete study assessment tools including the subject diary
* Female patients of childbearing potential must have a negative urine pregnancy test result and not be lactating.
* Likely to complete all required visits with no plans to move from Miami in the next 12 months
* Agree to not undergo other treatments or cosmetic procedures in the treatment area during the study such as facial laser treatments, botulinum toxin, hyaluronic acid injections, subcutaneous fat injections, any other permanent or semi-permanent facial fillers.
Exclusion Criteria:
* Any uncontrolled systemic disease
* History of any of the following conditions: vision loss not corrected by lenses or LASIX surgery; glaucoma, retinal detachment, macular degeneration, history of multiple sclerosis or optic neuritis, or any uncontrolled eye disease.
* Have a history of severe allergic/anaphylactic reactions or multiple allergies.
* Conditions within the treatment area including acne, scarring, acute lupus erythematosus, dermatitis, or melasma.
* Females planning to become pregnant, are pregnant, or are breast-feeding.
* History or current evidence of drug or alcohol abuse within 12 months prior to the screening visit
* Have severe thin skin, in the treatment area as determined by the PI.
* Have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months in the treatment area. Have had neuromodulator injections, mesotherapy, or resurfacing (laser or other ablative or non-ablative procedures) within 5 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study.
* Have undergone facial plastic surgery (with the exception of rhinoplasty or a brow lift), tissue grafting, or tissue augmentation with silicone, fat, or other permanent or semi-permanent dermal fillers or be planning to undergo any of these procedures affecting the treatment area, at any time during the study.
* Unwilling to undergo injections in the temple area.
* Have a history of migraines or frequent headaches, as determined by the PI.
* Have blindness or partial vision loss in either eye.
* Have received any other therapy, which, in the opinion of the investigator, could interfere with safety or efficacy evaluations.
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
* Patient who has a condition or is in a situation that, in the investigator's opinion, may put the patient at significant risk, or may significantly interfere with the patient's participation in the study.
* Have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g.,warfarin), anti-inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time from 10 days pre- to 3 days post injection. A wash out period of 10 days is allowed.
* Have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT02437903
Study Brief:
Protocol Section:
NCT02437903