Trial Outcomes & Findings for Efficacy and Safety of Tixel Treatment on Facial and/or Scalp Actinic Keratoses. (NCT NCT05365386)
NCT ID: NCT05365386
Last Updated: 2024-12-03
Results Overview
The overall mean percentage reduction in actinic keratoses lesion count performed by the investigator manually, confirmed and documented using photograph images taken at baseline and at 12 weeks follow-up visit (or 12-weeks post last treatment if less than 3 treatments were done) (before and after marking the present actinic keratoses using a washable eyeliner) calculated as the relative change from baseline at 12 weeks. New lesions which were not existed in baseline will not be counted.
COMPLETED
NA
20 participants
up to 12 weeks post last treatment
2024-12-03
Participant Flow
Participant milestones
| Measure |
Tixel Treatment
All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.
Tixel C: This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Tixel Treatment on Facial and/or Scalp Actinic Keratoses.
Baseline characteristics by cohort
| Measure |
Tixel Treatment
n=20 Participants
All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.
Tixel C: This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
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Age, Continuous
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67.7 years
STANDARD_DEVIATION 9.1 • n=5 Participants
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Sex: Female, Male
Female
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8 Participants
n=5 Participants
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Sex: Female, Male
Male
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12 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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20 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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20 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
Israel
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20 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: up to 12 weeks post last treatmentPopulation: per protocol population - subject lesion count change from baseline % at 12 weeks
The overall mean percentage reduction in actinic keratoses lesion count performed by the investigator manually, confirmed and documented using photograph images taken at baseline and at 12 weeks follow-up visit (or 12-weeks post last treatment if less than 3 treatments were done) (before and after marking the present actinic keratoses using a washable eyeliner) calculated as the relative change from baseline at 12 weeks. New lesions which were not existed in baseline will not be counted.
Outcome measures
| Measure |
Tixel Treatment
n=20 Participants
All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.
Tixel C: This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
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|---|---|
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Efficacy of Tixel for Treatment of Actinic Keratosis
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-90.4 percentage change
Standard Deviation 14.7
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SECONDARY outcome
Timeframe: up to 12 weeks post last treatmentPopulation: per protocol population - subject lesion count change from baseline at 4 and 12 weeks FU
The mean change in actinic keratoses lesion count, performed by the investigator manually, confirmed and documented using photograph images, from baseline at 4 and 12 weeks follow-up visit.
Outcome measures
| Measure |
Tixel Treatment
n=20 Participants
All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.
Tixel C: This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
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|---|---|
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Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis
Baseline - Total No. of leasions counted
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10.0 Number of lesions counted
Standard Deviation 9.7
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Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis
4 weeks FU - Total No. of lesions counted -Change from Baseline
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8.1 Number of lesions counted
Standard Deviation 6.8
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Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis
12 weeks FU - Total No. of lesions counted -Change from Baseline
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8.5 Number of lesions counted
Standard Deviation 6.9
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SECONDARY outcome
Timeframe: up to 4 weeks post last treatmentPopulation: per protocol population - subject lesion count change from baseline % at 4 weeks
The overall mean percentage reduction in actinic keratoses lesion count performed by the investigator manually, confirmed and documented using photograph images taken at baseline and at 4 weeks follow-up visit (before and after marking the present actinic keratoses using a washable eyeliner) calculated as the relative change from baseline at 4 weeks follow-up visit. New lesions which were not existed in baseline will not be counted.
Outcome measures
| Measure |
Tixel Treatment
n=20 Participants
All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.
Tixel C: This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
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|---|---|
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Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis
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-83.6 percentage change
Standard Deviation 16.9
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SECONDARY outcome
Timeframe: up to 12 weeks post last treatmentPopulation: Lesion count - relative change from baseline (by category)
* Percentage of subjects that demonstrate a 26-50% in reduction in actinic keratoses lesion count 3 months after the final treatment. * Percentage of subjects that demonstrate a 51-75% in reduction in actinic keratoses lesion count 3 months after the final treatment. * Percentage of subjects that demonstrate more than 76% in reduction in actinic keratoses lesion count 3 months after the final treatment.
Outcome measures
| Measure |
Tixel Treatment
n=20 Participants
All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.
Tixel C: This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
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Efficacy of Tixel for Treatment of Actinic Keratosis - Percentage of Subjects That Demonstrated Reduction in Actinic Keratosis Lesion Count 3 Months After the Last Treatment.
0-25%
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0 Participants
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Efficacy of Tixel for Treatment of Actinic Keratosis - Percentage of Subjects That Demonstrated Reduction in Actinic Keratosis Lesion Count 3 Months After the Last Treatment.
26-50%
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1 Participants
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Efficacy of Tixel for Treatment of Actinic Keratosis - Percentage of Subjects That Demonstrated Reduction in Actinic Keratosis Lesion Count 3 Months After the Last Treatment.
51-75%
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1 Participants
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Efficacy of Tixel for Treatment of Actinic Keratosis - Percentage of Subjects That Demonstrated Reduction in Actinic Keratosis Lesion Count 3 Months After the Last Treatment.
76-99%
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8 Participants
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Efficacy of Tixel for Treatment of Actinic Keratosis - Percentage of Subjects That Demonstrated Reduction in Actinic Keratosis Lesion Count 3 Months After the Last Treatment.
100%
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10 Participants
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SECONDARY outcome
Timeframe: up to 12 weeks post last treatmentPopulation: per protocol population - Experience questionnaire completed by the subjects
Subjects' satisfaction assessed at the final follow-up visit (based on the subject experience questionnaire which includes 3 questions relating to treatment results, treatment experience and treatment expectations) graded on a score of 1- 5; 1 being not satisfied and 5 being very satisfied).
Outcome measures
| Measure |
Tixel Treatment
n=20 Participants
All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.
Tixel C: This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
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To Evaluate the Subject's Satisfaction.
I am satisfied with the results of the treatment (Improvement Assessment) · Excellent - Very satisfied (score 5)
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19 Participants
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To Evaluate the Subject's Satisfaction.
I am satisfied with the results of the treatment (Improvement Assessment) · Good - Satisfied (score 4)
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1 Participants
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To Evaluate the Subject's Satisfaction.
I am satisfied with the results of the treatment (Improvement Assessment) · Moderately - satisfied (score 3)
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0 Participants
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To Evaluate the Subject's Satisfaction.
I am satisfied with the results of the treatment (Improvement Assessment) · Fair - Satisfied to some extent (score 2)
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0 Participants
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To Evaluate the Subject's Satisfaction.
I am satisfied with the results of the treatment (Improvement Assessment) · Poor - Poor or not satisfied at all (score 1)
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0 Participants
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To Evaluate the Subject's Satisfaction.
I am satisfied with the treatment experience · Excellent - Very satisfied (score 5)
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19 Participants
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To Evaluate the Subject's Satisfaction.
I am satisfied with the treatment experience · Good - Satisfied (score 4)
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1 Participants
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To Evaluate the Subject's Satisfaction.
I am satisfied with the treatment experience · Moderately - satisfied (score 3)
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0 Participants
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To Evaluate the Subject's Satisfaction.
I am satisfied with the treatment experience · Fair - Satisfied to some extent (score 2)
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0 Participants
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To Evaluate the Subject's Satisfaction.
I am satisfied with the treatment experience · Poor - Poor or not satisfied at all (score 1)
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0 Participants
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To Evaluate the Subject's Satisfaction.
The treatment has fulfilled my expectations · Excellent - Very satisfied (score 5)
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16 Participants
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To Evaluate the Subject's Satisfaction.
The treatment has fulfilled my expectations · Good - Satisfied (score 4)
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4 Participants
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To Evaluate the Subject's Satisfaction.
The treatment has fulfilled my expectations · Moderately - satisfied (score 3)
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0 Participants
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To Evaluate the Subject's Satisfaction.
The treatment has fulfilled my expectations · Fair - Satisfied to some extent (score 2)
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0 Participants
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To Evaluate the Subject's Satisfaction.
The treatment has fulfilled my expectations · Poor - Poor or not satisfied at all (score 1)
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0 Participants
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SECONDARY outcome
Timeframe: up to 12 weeks post last treatmentPopulation: safety population - Procedure-related Adverse Events reported
Procedure-related Adverse events during the study.
Outcome measures
| Measure |
Tixel Treatment
n=20 Participants
All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.
Tixel C: This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
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Safety Evaluation - Adverse Events
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0 Participants
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SECONDARY outcome
Timeframe: up to 4 weeks post last treatmentPopulation: Downtime was assessed at the FU visits post treatments.
Defined as the period of time following the procedure during which the subject felt unable/unwilling to go out in public due to skin reactions. The assessment will be recorded by the subject using the Subject Subjective Downtime Assessment following each treatment and will be collected at the site at the follow-up visits up to 4 weeks FU following treatment 3 (third treatment).
Outcome measures
| Measure |
Tixel Treatment
n=20 Participants
All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.
Tixel C: This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
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Subject Subjective Downtime Assessment
Follow-Up & Treatment 2. Time until return to work
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1.7 Hours
Standard Deviation 5.7
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Subject Subjective Downtime Assessment
Follow-Up & Treatment 2. Time until return to Social activities
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1.4 Hours
Standard Deviation 5.5
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Subject Subjective Downtime Assessment
Follow-Up & Treatment 2. Sensasion of heat
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7.8 Hours
Standard Deviation 19.6
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Subject Subjective Downtime Assessment
Follow-Up & Treatment 2.Redness
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44.3 Hours
Standard Deviation 48.7
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Subject Subjective Downtime Assessment
Follow-Up & Treatment 2. Edema
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10.7 Hours
Standard Deviation 22.9
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Subject Subjective Downtime Assessment
Follow-Up & Treatment 2. Scabs
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40.4 Hours
Standard Deviation 81.6
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Subject Subjective Downtime Assessment
Follow-Up & Treatment 3. Time until return to work
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1.4 Hours
Standard Deviation 5.5
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Subject Subjective Downtime Assessment
Follow-Up & Treatment 3. Time until return to Social activities
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4.1 Hours
Standard Deviation 12.0
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Subject Subjective Downtime Assessment
Follow-Up & Treatment 3. Sensation of heat
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0.7 Hours
Standard Deviation 2.8
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Subject Subjective Downtime Assessment
Follow-Up & Treatment 3.Redness
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33.4 Hours
Standard Deviation 55.2
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Subject Subjective Downtime Assessment
Follow-Up & Treatment 3. Edema
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1.3 Hours
Standard Deviation 5.5
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Subject Subjective Downtime Assessment
Follow-Up & Treatment 3. Scabs
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54.2 Hours
Standard Deviation 93.6
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Subject Subjective Downtime Assessment
4 weeks FU Time until return to work
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0.1 Hours
Standard Deviation 0.4
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Subject Subjective Downtime Assessment
4 weeks FU Time until return to Social activities
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0.2 Hours
Standard Deviation 0.7
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Subject Subjective Downtime Assessment
4 weeks FU sensation of heat
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1.5 Hours
Standard Deviation 5.3
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Subject Subjective Downtime Assessment
4 weeks FU Redness
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36.1 Hours
Standard Deviation 36.1
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Subject Subjective Downtime Assessment
4 weeks FU Edema
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2.5 Hours
Standard Deviation 7.4
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Subject Subjective Downtime Assessment
4 weeks FU Scabs
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36.0 Hours
Standard Deviation 59.0
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SECONDARY outcome
Timeframe: up to 8 weeks (treatments period)Population: The mean procedure-associated VAS scores reported by the subjects
Procedure related pain by the subjects using VAS for pain of 0-10 where a higher score indicates greater pain.
Outcome measures
| Measure |
Tixel Treatment
n=20 Participants
All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.
Tixel C: This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
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|---|---|
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VAS Assessment
mean procedure-associated VAS scores - treatment 1
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2.0 score on a scale
Standard Deviation 2.0
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VAS Assessment
mean procedure-associated VAS scores - treatment 2
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1.9 score on a scale
Standard Deviation 1.7
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VAS Assessment
mean procedure-associated VAS scores - treatment 3
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1.7 score on a scale
Standard Deviation 1.7
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Adverse Events
Tixel Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tixel Treatment
n=20 participants at risk
All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.
Tixel C: This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
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Gastrointestinal disorders
Diarrhea
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5.0%
1/20 • Number of events 1 • Adverse event data were collected from the initiation of the treatment until the end of the study period, and a total duration of 12 weeks of FU completion.
Reported adverse events.
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General disorders
Asthenia
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5.0%
1/20 • Number of events 1 • Adverse event data were collected from the initiation of the treatment until the end of the study period, and a total duration of 12 weeks of FU completion.
Reported adverse events.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
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5.0%
1/20 • Number of events 1 • Adverse event data were collected from the initiation of the treatment until the end of the study period, and a total duration of 12 weeks of FU completion.
Reported adverse events.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER