Evaluation of The Efficacy and Safety of Tixel Treatment for the Treatment of Facial and/or Scalp Actinic Keratoses

Study Overview
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Brief Summary
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Evaluation of the Efficacy and Safety of a thermal fractional skin treatment system (Tixel) for the treatment of facial and/or scalp actinic keratoses

Detailed Description
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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.

Official Title
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Evaluation of the Efficacy and Safety of a Thermal Fractional Skin Rejuvenation System (Tixel) for the Treatment of Facial and/or Scalp Actinic Keratoses

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Device: Tixel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 Skin Photo type I-VI Mild to moderate thickness confluent actinic keratoses located to scalp and/or face Subject is willing and able to comply with protocol requirements and all study visits Subject has provided a written informed consent Exclusion Criteria: Any patient who has undergone tanning during the 4 weeks prior to any treatment session and/or any patient who plans to undergo tanning during the 4 weeks following any treatment session (patients who may be exposed to the sun for short periods of time occasionally are not contra-indicated as long as they apply a high SPF sunscreen (>50). Current active Herpes Simplex infection. Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area. An impaired immune system condition or use of immunosuppressive medication. Collagen disorders, keloid formation and/or abnormal wound healing. Any patient who takes or has taken any medications (including via topical application), herbal treatment (oral or topic), food supplements or vitamins, which may cause fragile skin or impaired skin healing during the last 3 months. Any patient who has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment or less. Any patient who has a history of bleeding coagulopathies. Any patient who has tattoos or permanent makeup in the treated area. Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated. Women who are pregnant (as determined by self-reporting), lactating, or less than 3 months post-delivery, possibly pregnant or planning a pregnancy during the study period. Currently participating in or recently participated in another clinical trial (within the last 30 days). Age below 18 years. Subject underwent prior treatments for actinic keratoses including: Prior treatment with ablative laser, any laser or photo-dynamic therapy 3 months prior to enrollment. Any cryotherapy or electrodessication 6 weeks prior to enrollment. Systemic retinoid therapy within 6 months prior to enrollment. Topical treatment with 5-Fluorouracil cream and/or imiquimod cream and/or diclofenac gel and/or ingenol mebutate gel 6 months prior to enrollment. Face cannot be treated due to dermal disorder other than actinic keratoses, such as infection, surgical treatment etc. Subject has a systemic disease manifested by actinic keratoses (e.g. immune suppression). Significant systemic illness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-center, Prospective, Open Label, with Before-After Study Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tixel Treatment<br>This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology | Device: Tixel<br>* Non-invasive thermo-mechanical treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)] | 6 months | 
| Safety, number of Adverse Events | Any safety related event during the study will be record and analysed | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| Downtime Assessment | Subject will report the period of time following the procedure during which they had expected side effects | 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. | 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. | 3 months |