A Safety and Effectiveness Study of the Tixel Device, (Fractional Peri-orbital Wrinkles Treatment… (NCT03454672) | Clinical Trial Compass
TerminatedNot Applicable
A Safety and Effectiveness Study of the Tixel Device, (Fractional Peri-orbital Wrinkles Treatment ) Compared With Laser
Stopped: Delay in recruitment as per last protocol amendment due to Covid-19
United States, Israel68 participantsStarted 2018-03-12
Plain-language summary
This study is designed to explore the safety and the effectiveness of the Tixel device. This device performs fractional treatment of the skin by applying thermal (heat) energy to the skin. The study shall compare the safety and the effectiveness of the Tixel with the safety and the effectiveness of a laser device which is currently cleared for marketing in the US.
Who can participate
Age range40 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female 40-70 years old diagnosed with clinically evident fine (mild) to moderate depth periorbital wrinkling
✓. Willingness and ability to comply with all required study activities and protocol requirements.
✓. The subject is able to provide written informed consent and perform the study's activities according to HIPAA guidelines and/or Israeli law, depending on each specific study site.
Exclusion criteria
✕. The subject may not undergo treatment by the Tixel or comparator device according to the device's contra-indications for use, as defined in the User Manual and in the Instructions for Use and by any other labeling of the device.
✕. Female subjects who are pregnant, or planning to become pregnant, or have given birth less than 3 months ago or are lactating.
✕. Subjects with significant exposure to critical amounts of ultraviolet light (Sun tan).
✕. Subjects who have had the following treatments:
✕. a prior cosmetic procedure to improve facial rhytides (i.e., rhytidectomy, periorbital or eyelid/eyebrow surgery, brow lift, CO2/Erbium/similar laser/fractional resurfacing, radiofrequency treatment) within 12 months
What they're measuring
1
Mean Change by Blinded Assessor Evaluation by Fitzpatrick Classification of Facial Wrinkling (FWCS) Scale
✕. prior facial treatments with laser, surgical, chemical or light based facial treatments within the previous 6 months, such as for botulinum toxin injections, retinoid, microdermabrasion or prescription level glycolic acid treatments
✕. Injectable filler in area to be treated within 9 months of investigation.