Clinical Study Evaluating the Safety and Effectiveness of The Tixel Fractional System in The Trea… (NCT04639713) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study Evaluating the Safety and Effectiveness of The Tixel Fractional System in The Treatment of Periorbital Wrinkles
United States, Israel51 participantsStarted 2021-03-02
Plain-language summary
A Prospective, Multicenter, Single-Arm Clinical Study of 51 study subjects who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles. Up to 5 investigational centers in Israel and the United States will participate in the recruitment. Each study subject will receive four (4) treatments with Tixel in a monthly interval. Follow-up will occur 1 month and 3 months following last treatment.
Who can participate
Age range35 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female 35-70 years old diagnosed with clinically evident fine (mild) to moderate depth periorbital wrinkling
✓. Willingness and ability to comply with all required study activities including returning for follow-up visits 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.
✓. Fitzpatrick wrinkle score of 3-7 in the peri-orbital areas per the treating investigator and clinically noticeable wrinkles in the treating area.
✓. Stable body weight during the study period.
✓. Skin Type I - V as per Fitzpatrick Skin Scale
Exclusion criteria
✕. Past treatment with Tixel device.
✕. The subject may not undergo treatment by the Tixel 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.
✕. Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
✕. 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).
What they're measuring
1
Percentage of Participants With Safety Adverse Events
Timeframe: 6 months
2
The Mean Improvement and Treatment Effectiveness by Blinded Assessors Using Using the Fitzpatrick Wrinkle Classification Scale (FWCS) Evaluation
✕. Subjects who have had the following treatments:
✕. a cosmetic procedure to improve peri-orbital rhytides (i.e. periorbital or eyelid/eyebrow surgery, brow lift, CO2/Erbium/similar laser/fractional resurfacing, radiofrequency treatment) within 12 months
✕. prior facial treatments with laser, surgical, chemical or light-based facial treatments within the previous 12 months, over the periorbital area including botulinum toxin injections, microdermabrasion or prescription level glycolic acid treatments.