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CompletedNCT04527653Updated Jun 4, 2021

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

An interventional study of Tixel in Actinic Keratoses, sponsored by Novoxel Ltd.. Completed at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-06-04.

Sponsored by Novoxel Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2020, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Actinic Keratoses

Browse trials for

03

In context

Keratosis, Actinic

343 studies on the registry are indexed under Keratosis, Actinic; 29 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 295 interventional studies indexed under Keratosis, Actinic.

Browse Keratosis, Actinic studies →

Lead sponsor

Novoxel Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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 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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Tixel Treatment

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

    Device: Tixel

Interventions

  • DeviceTixel

    Non-invasive thermo-mechanical treatment

06

What researchers measure

Primary outcomes

  1. 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)\]

    Time frame: 6 months

  2. Safety, number of Adverse Events

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

    Time frame: 6 months

Secondary outcomes

  1. 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".

    Time frame: 6 months

  2. Downtime Assessment

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

    Time frame: 4 moths

  3. 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".

    Time frame: 3 months

  4. 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.

    Time frame: 3 months

07

Study locations

1 site
  • Rabin Medical Center, Ha'Sharon Campus
    Petach Tikva, 49100, Israel
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2020 to primary completion in Apr 2021, 11 months.

Of 33 interventional studies with no phase under Keratosis, Actinic, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 33. This study's 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2020
First posted
Aug 26, 2020
StartActual
May 14, 2020
Primary completionActual
Apr 19, 2021
CompletionActual
Apr 19, 2021
Last update
Jun 4, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04527653
Lead sponsor
Novoxel Ltd.
Responsible party
Sponsor
First posted
Aug 26, 2020
Start date
May 14, 2020
Primary completion
Apr 19, 2021
Completion
Apr 19, 2021
Last update
Jun 4, 2021

Study contacts

Assi Levi, MD
principal investigator · Rabin Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Novoxel Ltd.

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