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

Primary Purpose

Actinic Keratoses

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Tixel

About this trial

This is an interventional treatment trial for Actinic Keratoses

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rabin Medical Center, Ha'Sharon Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tixel Treatment

Arm Description

This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology

Outcomes

Primary Outcome Measures

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)]

Safety, number of Adverse Events

Any safety related event during the study will be record and analysed

Secondary Outcome Measures

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".

Downtime Assessment

Subject will report the period of time following the procedure during which they had expected side effects

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".

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.

Full Information

NCT ID

NCT04527653

First Posted

August 17, 2020

Last Updated

June 2, 2021

Sponsor

Novoxel Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04527653

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

May 14, 2020 (Actual)

Primary Completion Date

April 19, 2021 (Actual)

Study Completion Date

April 19, 2021 (Actual)

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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)

Masking Description

The mean of the improvement in actinic keratosis performed by two independent dermatologists using photograph images taken at baseline and at 4, 12-weeks follow-up visits.

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tixel Treatment

Arm Type

Experimental

Arm Description

This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology

Intervention Type

Device

Intervention Name(s)

Tixel

Intervention Description

Non-invasive thermo-mechanical treatment

Primary Outcome Measure Information:

Title

Blinded Evaluation of Improvement

Description

Time Frame

6 months

Title

Safety, number of Adverse Events

Description

Any safety related event during the study will be record and analysed

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Subject Satisfaction Assessments

Description

Time Frame

6 months

Title

Downtime Assessment

Description

Subject will report the period of time following the procedure during which they had expected side effects

Time Frame

4 moths

Title

Discomfort Assessment

Description

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

Title

Expected immediate response

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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