A Prospective, Single Center, Single-Arm Clinical Study of 20 Participants to Reduce the Appearan… (NCT05282979) | Clinical Trial Compass
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A Prospective, Single Center, Single-Arm Clinical Study of 20 Participants to Reduce the Appearance of the Peri-orbital Wrinkles. Participants Will Receive up to Four Treatments With Tixel Every 4 Weeks. Follow-up Will Occur 1 Month and 3 Months Following Last Treatment.
United States20 participantsStarted 2021-08-20
Plain-language summary
A Prospective, Single center, Single-Arm Clinical Study of 13-20 study participants who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles. Each study participant will receive up to four (4) treatments with the Tixel in a monthly interval. Follow-up will occur 1 month and 3 months following last treatment.
Who can participate
Age range35 Years – 75 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 35-75 years old diagnosed with clinically evident fine (mild) to moderate depth periorbital wrinkles.
✓. 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.
✓. Fitzpatrick wrinkle score of 3-7 in the peri-orbital areas per the treating investigator.
✓. 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 (Suntan).
What they're measuring
1
Safety Adverse Events report
Timeframe: Up to 12 months
2
Effectiveness using Fitzpatrick Wrinkle Classification Scale (FWCS)