Actinic KeratosesNCT05365386
Efficacy and Safety of Tixel Treatment on Facial and/or Scalp Actinic Keratoses.
A study testing Tixel C in people with Actinic Keratoses, run by Novoxel Ltd. at 1 site in Israel.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Tixel C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 17 May 2022to 12 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Evaluation of the Efficacy and Safety of a thermal fractional skin treatment system (Tixel) for the treatment of facial and/or scalp actinic keratoses
Read the 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).
- Conditions
- Actinic Keratoses
- Being tested
- Tixel C
- Keywords
- actinic keratoses.
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tixel CDevice
This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
| Study group | Role | What they receive |
|---|---|---|
| Tixel Treatment | Experimental | All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device. Receives: Device: Tixel C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 weeks post last treatment
Secondary outcomes (7)
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.
Measured: 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.
Measured: up to 4 weeks post last treatment
Efficacy of Tixel for Treatment of Actinic Keratosis - Percentage of Subjects That Demonstrated Reduction in Actinic Keratosis Lesion Count 3 Months After the Last Treatment.
- 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.
Measured: 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).
Measured: up to 12 weeks post last treatment
Safety Evaluation - Adverse Events
Procedure-related Adverse events during the study.
Measured: 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).
Measured: 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.
Measured: up to 8 weeks (treatments period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start17 May 2022
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, Prospective, Open Label, with Before-After Study Design.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novoxel Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Assi Levi, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365386
- Sponsor's protocol ID
- CLN 0827
- Status last verified
- Nov 2024
- First submitted
- 23 Mar 2022
- Last updated
- 3 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05365386
- Acronym / sponsor ID
- CLN 0827
- Conditions
- Actinic Keratoses
- Keywords
- actinic keratoses.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Novoxel Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 May 2022 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Posted 3 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, Prospective, Open Label, with Before-After Study Design.
| Arm | Type | Receives |
|---|---|---|
| Tixel Treatment | Experimental | Device: Tixel CAll subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tixel CThis is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology. | Device | Tixel Treatment |
Primary outcome
Efficacy of Tixel for Treatment of Actinic Keratosis
Time frame: up to 12 weeks post last treatment
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.
7 secondary outcomes
Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis
Time frame: up to 12 weeks post last treatment
Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis
Time frame: up to 4 weeks post last treatment
Efficacy of Tixel for Treatment of Actinic Keratosis - Percentage of Subjects That Demonstrated Reduction in Actinic Keratosis Lesion Count 3 Months After the Last Treatment.
Time frame: up to 12 weeks post last treatment
To Evaluate the Subject's Satisfaction.
Time frame: up to 12 weeks post last treatment
Safety Evaluation - Adverse Events
Time frame: up to 12 weeks post last treatment
Subject Subjective Downtime Assessment
Time frame: up to 4 weeks post last treatment
VAS Assessment
Time frame: up to 8 weeks (treatments period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assi Levi, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tixel C in people with Actinic Keratoses, run by Novoxel Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Tixel for Treatment of Actinic Keratosis (time frame: up to 12 weeks post last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.