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.
A Prospective, Single center, Single-Arm Clinical Study of 13-20 participants who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles, and meet study eligibility criteria, and have provided informed consent will be enrolled in the study. Each study participate will receive up to 4 treatments with Tixel in monthly interval. Follow-up will occur at 1 month and 3 months following the last visit. The clinic visits will be as follow: 1. Base line (1st tx) 2. Phone-call visit (3 days after the first treatment) 3. 4 week (2nd tx) 4. 8 week (3rd tx) 5. 12 week (4th tx) 6. 4 weeks after the last treatment (1st Follow-up) 7. 12 weeks after the last treatment (2nd follow-up = 3 months follow-up, primary endpoint and the study completion visit) Primary Safety Endpoint is the evaluation of related adverse events up to the 3-month visit after treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide dermal remodeling and collagen restructuring that promote wrinkles appearance improvement.
Physicians Laser & Dermatology Institute, LLC
Chicago, Illinois, United States
RECRUITINGSafety Adverse Events report
Evaluation of related adverse events up to the 3-month after last treatment visit
Time frame: Up to 12 months
Effectiveness using Fitzpatrick Wrinkle Classification Scale (FWCS)
Comparison of the proportion of subjects with a ≥ 1-score improvement on the Fitzpatrick Wrinkle Classification Scale (FWCS) at the 3-month visit compared to baseline. The FWCS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower score is considered better.
Time frame: Up to 12 months
Effectiveness using Fitzpatrick Wrinkle Classification Scale (FWCS)- Unblinded
Assessment of improvement using Fitzpatrick Wrinkle Classification Scale (FWCS) at each visit compared to baseline by the handling physician. The FWCS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower score is considered better.
Time frame: Up to 12 months
Effectiveness using GAIS-Global Aesthetic Improvement Scale Assessment-Unblinded
Assessment of improvement using Global Aesthetic Improvement Scale Assessment at 1 month and 3 month follow up compared to baseline by the handling physician. Rating: 1\) Exceptional improvement patient; 2) Very improved patient; 3) Improved patient; 4)Unaltered patient; 5) Worsened patient
Time frame: Up to 12 months
Evaluation of the pain and discomfort
Evaluation of the pain and discomfort of the treatment as reported by the subject on a visual analog scale (VAS). Scoring will consist of making a mark on a 10-point scale. Each line will be awarded a score of 0-10 according to the level of pain when 0 is no pain and 10 is maximum pain possible.
Time frame: Up to 12 months
Subject Subjective Downtime Assessment
Evaluation of the period of time following the procedure during which the subject felt unable/unwilling to go out in public.
Time frame: Up to 12 months
Patients' Reported Outcomes
Subject Satisfaction Questionnaire and GAIS- Global Aesthetic Improvement Scale Assessment. Rating: 1) Exceptional improvement patient; 2) Very improved patient; 3) Improved patient; 4) Unaltered patient; 5) Worsened patient
Time frame: Up to 12 months
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