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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
New York Laser & Skin Care
New York, New York, United States
Dr. Artzi Skin Center Clinic - Linked to Hillel Yaffe Medical Center
Tel Aviv, Israel
Mean Change by Blinded Assessor Evaluation by Fitzpatrick Classification of Facial Wrinkling (FWCS) Scale
The FWCS shall be assessed and quantified by 3 blinded assessors comparing baseline visit to +42 weeks visit.
Time frame: baseline, 42 Weeks
Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score
Subjective satisfaction is scored on a scale from 1-5, from excellent (5-very satisfied) to poor (1-poor or not satisfied at all). compring results from baseline to 42 weeks. total minimum total score - 3, total maximum score - 15
Time frame: Treatment 1 (Baseline), Treatment 4 (Week 12), Treatment 5 (Week 16), Follow-up Visit 1 (Week 20), Follow-up Visit 3 (Week 42)
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
This assessment determines the number of days required for the subject to return to normal, daily activities. This will be assessed at each treatment visit : visit 1 - visit 5. The downtime assessment was evaluated after each Tixel treatment visit. The therapist asked the subject in the next visit regarding the 3 parameters that relate to the total downtime assessment. The parameters were: 1. Return to work (Days) 2. Return to social activities (Days) 3. Scabs (Days) The results for subjective Downtime assessments were grouped by two categories: * More than 2 days vs. less or equal to 2 days for Return to work, Return to social activities, Redness, Edema, and Scabs. * More than 4 hours vs. less or equal to 4 hours for sensation of heat.
Time frame: visit 1 - visit 5
Pain Level as Measured by the Visual Analog Scale (VAS) Scale
Secondary Safety- VAS is scored on a scale from 0-10, with 0 indicating no pain and 10 indicating worst pain. This will be assessed at each treatment over 8 weeks to 16 weeks (Depending on number of Treatments given).
Time frame: treatment 1 - treatment 5
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number on End-User Experience Scale
The scores were converted to the same scale (a minimal score of 10 and a maximal score of 100 ) for both treatments, where a score of 10 is considered the wors outcome, and a score of 100 is considered the better outcome. For ResurFX, the maximal score is 45 therefore, the transformed score= total score \*45 /100; for Tixel the maximal score is 50 therefore the transformed score =\*50/100.
Time frame: After performing 5 treatments with each device. After performing between 20 or 30 treatments with each device. After completing all the required treatments in the investigator's study site with both devices.
Mean Score Performance as Measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS)
The FWCS shall be assessed and quantified by the handling physician at study visits 1-8. The FWCS is classified as I-III, where I indicated mild/fine wrinkles and III indicates moderate wrinkles. (baseline to 42 weeks)
Time frame: baseline, 42 Weeks
Mean Improvement Performance as Measured by Improvement Global Assessment
Improvement Global Assessment is scored on a scale from 1-4, with 1 indicating a poor response and 4 indicating an excellent response. This will be assessed at study visits 2-8. (from week 4- week 42)
Time frame: visit 2, 3, 4, follow up 1, 2, 3
Mean Score of Performance as Measured by 5-point Wrinkle Assessment Scale (WAS)
The 5-point WAS is scored on a scale from 0-4, with 0 indicating no visible wrinkles and 4 indicating very deep wrinkles. This will be assessed at study visits 1-8. (baseline to 42 weeks)
Time frame: 42 Weeks