Actinic KeratosesNCT04527653
Evaluation of The Efficacy and Safety of Tixel Treatment for the Treatment of Facial and/or Scalp Actinic Keratoses
A study testing Tixel 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
- 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
- 14 May 2020to 19 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
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 21Show fewer
- 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.
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 Rejuvenation 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 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.
- Conditions
- Actinic Keratoses
- Being tested
- Tixel
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TixelDevice
Non-invasive thermo-mechanical treatment
| Study group | Role | What they receive |
|---|---|---|
| Tixel Treatment | Experimental | This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology Receives: Device: Tixel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)]
Measured: 6 months
Safety, number of Adverse Events
Any safety related event during the study will be record and analysed
Measured: 6 months
Secondary outcomes (4)
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".
Measured: 6 months
Downtime Assessment
Subject will report the period of time following the procedure during which they had expected side effects
Measured: 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".
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start14 May 2020
- Primary completion19 Apr 2021
- Study completion19 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- NCT04527653
- Sponsor's protocol ID
- CLN 0732
- Status last verified
- Jun 2021
- First submitted
- 17 Aug 2020
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. 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 Rejuvenation System (Tixel) for the Treatment of Facial and/or Scalp Actinic Keratoses
- ClinicalTrials.gov ID
- NCT04527653
- Acronym / sponsor ID
- CLN 0732
- Conditions
- Actinic Keratoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Novoxel Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 May 2020 (actual)
- Primary completion
- 19 Apr 2021 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
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 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.
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: TixelThis is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 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 |
|---|---|---|
| TixelNon-invasive thermo-mechanical treatment | Device | Tixel Treatment |
Primary outcome
Blinded Evaluation of Improvement
Time frame: 6 months
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
Time frame: 6 months
Any safety related event during the study will be record and analysed
4 secondary outcomes
Subject Satisfaction Assessments
Time frame: 6 months
Downtime Assessment
Time frame: 4 moths
Discomfort Assessment
Time frame: 3 months
Expected immediate response
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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 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 21 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 4 Jun 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blinded Evaluation of Improvement (time frame: 6 months). The study lists 2 primary outcomes in all. 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 4 Jun 2021.