Back to resultsEfficacy and Safety of Tixel Treatment on Facial and/or Scalp Actinic Keratoses.
Primary Purpose
Actinic Keratoses
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tixel C
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratoses focused on measuring actinic keratoses.
Eligibility Criteria
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.
Sites / Locations
- Rabin Medical Center, Ha'Sharon CampusRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tixel Treatment
Arm Description
All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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).
Safety evaluation - Adverse Events
Procedure related AEs
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).
VAS assessment
Procedure related pain by the subjects using VAS for pain of 0-10 where a higher score indicates greater pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05365386
Brief Title
Efficacy and Safety of Tixel Treatment on Facial and/or Scalp Actinic Keratoses.
Official Title
Evaluation of the Efficacy and Safety of a Thermal Fractional Skin Treatment System (TIXEL®) for the Treatment of Facial and / or Scalp Actinic Keratoses.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
April 5, 2023 (Anticipated)
Study Completion Date
April 5, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novoxel Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses
Keywords
actinic keratoses.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-center, Prospective, Open Label, with Before-After Study Design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tixel Treatment
Arm Type
Experimental
Arm Description
All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.
Intervention Type
Device
Intervention Name(s)
Tixel C
Intervention Description
This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
Primary Outcome Measure Information:
Title
Efficacy of Tixel for treatment of actinic keratosis
Description
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
Secondary Outcome Measure Information:
Title
Efficacy Evaluation of Tixel for treatment of actinic keratosis
Description
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
Title
Efficacy Evaluation of Tixel for treatment of actinic keratosis
Description
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
Title
Efficacy of Tixel for treatment of actinic keratosis
Description
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.
Time Frame
up to 12 weeks post last treatment
Title
To Evaluate the subject's satisfaction.
Description
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
Title
Safety evaluation - Adverse Events
Description
Procedure related AEs
Time Frame
up to 12 weeks post last treatment
Title
Subject subjective downtime assessment
Description
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
Title
VAS assessment
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hila Kfir, b.sc
Phone
0523313350
Email
hilaz28@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ifat Klein, P.hd
Phone
972-526009860
Email
ifat@novoxel.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assi Levi, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center, Ha'Sharon Campus
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Assi Levi, MD
Phone
+972504048730
Email
assile@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Igor Snast, MD
Phone
972-50-7591-805
Email
SNASTIGOR@GMAIL.COM
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy and Safety of Tixel Treatment on Facial and/or Scalp Actinic Keratoses.
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