Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid (NCT07028203) | Clinical Trial Compass
By InvitationNot Applicable
Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid
United States30 participantsStarted 2024-11-05
Plain-language summary
The goal of this clinical trial is to determine the BTL-785-7-11 applicator effectiveness for an under-eye appearance improvement by evaluation of the periorbital area in healthy adult volunteers. The main question it aims to answer is:
Whether the BTL-785-7-11 applicator is able to improve the periorbital area post-treatment, as assessed by the analysis of 3D photographs.
Participants will complete four treatments and two follow-up visits.
Who can participate
Age range21 Years
SexALL
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Inclusion Criteria:
* Healthy male or female subjects over 21 years of age seeking aesthetic improvement of the periorbital area
* Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
* Presence of clearly visible aging signs in the periorbital area (e.g. under-eye bags, periorbital wrinkles) when the face is relaxed as deemed appropriate by the Investigator
* Subjects willing and able to abstain from partaking in any facial treatments other than the study procedure during study participation
* Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face taken
Exclusion Criteria:
* Lower eyelid malposition (ectropion, entropion, retraction)
* Blepharitis
* Prior lower eyelid fat removal, skin resection, eyelid surgery or orbital trauma in the past 6 months, prior dermatochalasis of lower eyelids surgical treatment in the past 6 months
* Filler injections in the treatment area and midface region within 3 months prior to the study participation
* Neuromodulator treatment in the periorbital area within 3 months prior to the study participation
* Tattoo(s) and/or permanent make-up in the intended treatment area
* Prior usage within 30 days before the screening or planned usage during the study of retinol, or any medication that can cause dermal hypersensitivity
* Bacterial or viral infection, acute ā¦