Efficacy and Safety of Tixel Treatment on 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 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).

Official Title
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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.

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Device: Tixel C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female, age 18-80 years old. Skin Phototype I-VI. Subject has mild to moderate thickness confluent AKs on his/her scalp and/or face. Subject is willing and able to comply with protocol requirements and all study visits. Subject has provided 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 retinoids within 6 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). 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 6 months prior to enrollment. Prior treatment with Tixel. Face cannot be treated due to dermal disorder other than AKs, such as infection, surgical treatment etc. Subject has a systemic disease manifested by AKs (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>All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device. | Device: Tixel C<br>* This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 12 weeks post last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | up to 4 weeks post last treatment | 
| Efficacy of Tixel for treatment of actinic keratosis | 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. | 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). | up to 12 weeks post last treatment | 
| Safety evaluation - Adverse Events | Procedure related AEs | 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). | 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. | up to 8 weeks (treatments period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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actinic keratoses.