Evaluation of the Efficacy and Safety of a thermal fractional skin treatment system (Tixel) for the treatment of facial and/or scalp actinic keratoses
Single-center, Prospective, Open-Label, with Before-After Study Design. Up to 25 subjects will be enrolled to the study to provide at least 20 evaluable subjects. Subjects will be examined to determine the severity and extent of actinic keratoses. All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart. Follow-up visits will be performed after the last treatment visit: 4 weeks (±7 days) and 12 weeks (±7 days). The inclusion criteria would be mild to moderate thickness confluent actinic keratoses located to scalp and/or face. Each subject will participate in the study for up to 20 weeks. Total study duration is estimated to be up to 12 months from enrollment of the first subject until last subject visit (including FUs).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
Rabin Medical Center, Ha'Sharon Campus
Petah Tikva, Israel
Efficacy of Tixel for Treatment of Actinic Keratosis
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.
Time frame: up to 12 weeks post last treatment
Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis
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.
Time frame: up to 12 weeks post last treatment
Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis
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.
Time frame: up to 4 weeks post last treatment
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.
* 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.
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Time frame: up to 12 weeks post last treatment
To Evaluate the Subject's Satisfaction.
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).
Time frame: up to 12 weeks post last treatment
Safety Evaluation - Adverse Events
Procedure-related Adverse events during the study.
Time frame: up to 12 weeks post last treatment
Subject Subjective Downtime Assessment
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).
Time frame: up to 4 weeks post last treatment
VAS Assessment
Procedure related pain by the subjects using VAS for pain of 0-10 where a higher score indicates greater pain.
Time frame: up to 8 weeks (treatments period)