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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT05647551
Eligibility Criteria:
Inclusion Criteria:
* Participant's dissatisfaction with eyes, measured by a baseline score of "very dissatisfied" or "somewhat dissatisfied" in at least 3 of the 7 items in the FACE-Q Satisfaction with Eyes.
* Have some degree of IOH/TT per Allergan Infraorbital Hollows Scale (AIHS) (1 \[minimal\], 2 \[moderate\], 3 \[severe\], or 4 \[extreme\]) on both sides with a chance of improvement either by direct or indirect treatment, per investigator's assessment.
* Need for treatment in at least 2 areas in the upper and/or mid face (e.g., eyebrows, IOH/TT, temples, malar or zygomatic, fine lines such as periorbital lines), with at least two of the JUVÉDERM products (Juvéderm VOLBELLA, Juvéderm VOLIFT, or Juvéderm VOLUMA), per investigator's assessment.
* Participant meets at least one of the following criteria (investigator's assessment):
* 2 or 3 (moderate or severe) on Allergan Glabellar Lines Severity Scale at maximum furrow.
* 2 or 3 (moderate or severe) on Lateral Canthal Lines Severity Scale at maximum smile.
* Participants must have a score of ≥ 5 for Facial Line Outcomes-11 item 1 (Bothered by Facial Lines).
Exclusion Criteria:
* Participants with presence of inflammation, infection at any injection site or systemic infection (study entry may be postponed until one week following recovery), noticeable acne scarring, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated.
* Participant with an allergy or sensitivity to investigational products or their components.
* Participant with history or current symptoms of dysphagia.
* Participant has medical condition that may increase the risk of exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
* Participant has profound atrophy/excessive weakness of muscles in target areas of injection.
* Participant has marked facial asymmetry, brow or eyelid ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen the resting Glabellar Lines (GLs) and Lateral Canthal Lines (LCLs)/facial rhytides by physically spreading them apart.
* Participant has tendency to accumulate fluid in the lower eyelids, or large infraorbital fat pads, i.e., significant convexity or projection from the infraorbital fat pads that would mask improvement.
* Participant has mid face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or human immunodeficiency virus-related disease.
* Participant has undergone live vaccination, surgery, or dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 30 days prior to enrollment or be planning to undergo any of these procedures during the study and up to 30 days after the study.
* Participant has neuromuscular disorders including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise.
* Participant has received temporary or semi-permanent filler injections at upper or mid face (e.g., HA, calcium hydroxyapatite, L-polylactic acid) within 2 years prior to entry in the study.
* Participant has received any investigational product or device within 30 days or 5 half-lives of the drug (whichever is longer) prior to study enrollment or planning to participate in another investigation during the course of this study.
* Participant has undergone at anytime plastic surgery of the face, tissue grafting, or tissue augmentation with silicone, fat, or other permanent dermal fillers, or be planning to undergo any of these procedures at any time during the study.
* Participant has received mesotherapy, skin resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or non-ablative procedures) in the face within 6 months prior to study enrollment.
* Participant has a current use of nonsteroidal anti-inflammatory drug (e.g., aspirin, ibuprofen) with the exception of a daily low dose of aspirin, from 10 days prior to injection up to 3 days post-injection.
* Participant has had topical retinoid therapy and/or topical hormone cream applied to the face, for potential participants who have not been on a consistent dose regimen for at least 6 months prior to enrollment and who are unable to maintain regimen for the study.
* Participant has received systemic retinoid therapy within one year prior to study enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT05647551
Study Brief:
Protocol Section:
NCT05647551