Trial Outcomes & Findings for Clinical Study Evaluating the Safety and Effectiveness of The Tixel Fractional System in The Treatment of Periorbital Wrinkles (NCT NCT04639713)

NCT ID: NCT04639713

Last Updated: 2024-03-19

Results Overview

Evaluation of related adverse events up to the 3-month after a treatment visit.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 51 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-03-19

Participant Flow

Participant milestones

Measure	Tixel 2 Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject would be questioned about pain level, subjective dountime assessment and subjective response assessment. Images would be taken at baseline and in Follow-Up visits Tixel 2: 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.
Overall Study STARTED	51
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Tixel 2 Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject would be questioned about pain level, subjective dountime assessment and subjective response assessment. Images would be taken at baseline and in Follow-Up visits Tixel 2: 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.
Overall Study Protocol Noncompliance	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Clinical Study Evaluating the Safety and Effectiveness of The Tixel Fractional System in The Treatment of Periorbital Wrinkles

Baseline characteristics by cohort

Measure	Tixel 2 n=51 Participants Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject would be questioned about pain level, subjective dountime assessment and subjective response assessment. Images would be taken at baseline and in Follow-Up visits Tixel 2: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	56.8 years STANDARD_DEVIATION 7.42 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Region of Enrollment Israel	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Evaluation of related adverse events up to the 3-month after a treatment visit.

Outcome measures

Measure

Tixel 2 n=51 Participants Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject would be questioned about pain level, subjective dountime assessment and subjective response assessment. Images would be taken at baseline and in Follow-Up visits Tixel 2: 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.

Percentage of Participants With Safety Adverse Events

3.92 Percentage of Participants

PRIMARY outcome

Timeframe: baseline and at 3 months

Population: subjects who received at least one tixel treatment

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 as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. 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.

Outcome measures

Measure	Tixel 2 n=48 Participants Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject would be questioned about pain level, subjective dountime assessment and subjective response assessment. Images would be taken at baseline and in Follow-Up visits Tixel 2: 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.
The Mean Improvement and Treatment Effectiveness by Blinded Assessors Using Using the Fitzpatrick Wrinkle Classification Scale (FWCS) Evaluation Assessed by evaluator #1	2.00 score on a scale Standard Deviation 0.83
The Mean Improvement and Treatment Effectiveness by Blinded Assessors Using Using the Fitzpatrick Wrinkle Classification Scale (FWCS) Evaluation Assessed by evaluator #2	2.17 score on a scale Standard Deviation 0.71
The Mean Improvement and Treatment Effectiveness by Blinded Assessors Using Using the Fitzpatrick Wrinkle Classification Scale (FWCS) Evaluation Assessed by evaluator #3	1.19 score on a scale Standard Deviation 0.55

SECONDARY outcome

Timeframe: Baseline and 3 months visits

Population: subjects who received Tixel treatments

Assessment of improvement using Global Aesthetic Improvement Scale Assessment at each visit compared to baseline by the handling physician. Rating:

1) expectational improvement; 2) very improved patient; 3) Improved patient; 4) Unaltered patient; 5) Worsened patient

Outcome measures

Measure	Tixel 2 n=48 Participants Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject would be questioned about pain level, subjective dountime assessment and subjective response assessment. Images would be taken at baseline and in Follow-Up visits Tixel 2: 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.
The Mean Evaluation of Improvement Assessed by the Handling Physician by Using GAIS Scale - Global Aesthetic Improvement Scale Assessment GAIS at visit 5 - 1 month FU	3.54 score on a scale Standard Deviation 0.68
The Mean Evaluation of Improvement Assessed by the Handling Physician by Using GAIS Scale - Global Aesthetic Improvement Scale Assessment GAIS at visit 6 - 3 months FU	3.52 score on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: Up to 6 months

Population: pain and discomfort following treatment, reported by the subjects who treated with tixel

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-points 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 the maximum pain possible.

Outcome measures

Measure	Tixel 2 n=51 Participants Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject would be questioned about pain level, subjective dountime assessment and subjective response assessment. Images would be taken at baseline and in Follow-Up visits Tixel 2: 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.
The Mean Score Evaluation of the Pain and Discomfort for Each Treatment procedure-associated VAS - treatment 1	2.98 score on a scale Standard Deviation 1.52
The Mean Score Evaluation of the Pain and Discomfort for Each Treatment procedure-associated VAS - treatment 2	2.94 score on a scale Standard Deviation 1.14
The Mean Score Evaluation of the Pain and Discomfort for Each Treatment procedure-associated VAS - treatment 3	2.82 score on a scale Standard Deviation 1.22
The Mean Score Evaluation of the Pain and Discomfort for Each Treatment procedure-associated VAS - treatment 4	2.81 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: up to 6 months

Population: subject who treated with tixel

Subject Experience (Satisfaction) questionnaire - Subjects assessed their satisfaction at the follow up visits. The following parameters were assessed: results of treatment, treatment experience and expectations (indicating whether the treatment has fulfilled the subject's expectations). For each parameter, the assessment was based on a 5-point scale: 1 = "Poor - Poor or not satisfied at all", 2 ="Fair - satisfied to some extent", 3 = "Moderately - Satisfied", 4 = "Good - Satisfied", 5 = "Excellent - Very Satisfied".

Outcome measures

Measure	Tixel 2 n=48 Participants Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject would be questioned about pain level, subjective dountime assessment and subjective response assessment. Images would be taken at baseline and in Follow-Up visits Tixel 2: 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.
Satisfaction Questionnaire 'Very satisfied' with the results of the treatment	23 Participants
Satisfaction Questionnaire 'Very satisfied' with the treatment experience	33 Participants
Satisfaction Questionnaire 'Very satisfied' with regard to their expectations from treatment	21 Participants

Adverse Events

Tixel 2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tixel 2 n=51 participants at risk Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject would be questioned about pain level, subjective dountime assessment and subjective response assessment. Images would be taken at baseline and in Follow-Up visits Tixel 2: 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.
Skin and subcutaneous tissue disorders Erythema	2.0% 1/51 • Number of events 1 • 6 months
Musculoskeletal and connective tissue disorders Back Pain	2.0% 1/51 • Number of events 1 • 6 months

Additional Information

Ifat Klein

Novoxel Ltd

Phone: 972-52-6009860

Email: ifat@novoxel.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER