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 their clinical improvement), 3-4 weeks apart. Follow-up visits after the last treatment visit: 4 weeks (±7 days), 12 weeks (±7 days), 52 weeks (±14 days) - the last follow up visit is a voluntary one. The inclusion criteria would be mild to moderate thickness confluent actinic keratoses located to scalp and/or face.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Non-invasive thermo-mechanical treatment
Rabin Medical Center, Ha'Sharon Campus
Petah Tikva, Israel
Blinded Evaluation of Improvement
lesions count as well as an evaluation of the overall improvement in facial appearance based on a quartile scale of improvement graded as 0 (exacerbation) 1 (1-25% improvement), 2 (26-50% improvement), 3 (51-75% improvement) or 4 (76-100% improvement)\]
Time frame: 6 months
Safety, number of Adverse Events
Any safety related event during the study will be record and analysed
Time frame: 6 months
Subject Satisfaction Assessments
Subjects will assess their satisfaction with the procedure on FU visit. The assessment will be based on a 5-point Likert scale detailed in Table 4 where 0 represents "very dissatisfied" and 4 represents "very satisfied".
Time frame: 6 months
Downtime Assessment
Subject will report the period of time following the procedure during which they had expected side effects
Time frame: 4 moths
Discomfort Assessment
Subject will assess their pain level following each treatment via Pain Visual Analogue Scale (VAS), were 0 is "no pain" and 10 is "intolerable pain".
Time frame: 3 months
Expected immediate response
Investigator will assess expected immediate response and will document immediately post treatment using a 4-level scale: (0) None / (1) Mild / (2) Moderate / (3) Severe on each treatment visit.
Time frame: 3 months
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