An interventional study of Tixel C 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 2024-12-03.
Sponsored by Novoxel Ltd. · Not applicable, Interventional, and Treatment
Evaluation of the Efficacy and Safety of a thermal fractional skin treatment system (Tixel) for the treatment of facial and/or scalp actinic keratoses
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).
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 →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.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.
Device: Tixel C
This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
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.
Time frame: up to 12 weeks post last treatment
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.
Time frame: 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.
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.
* 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
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).
Time frame: up to 12 weeks post last treatment
Safety Evaluation - Adverse Events
Procedure-related Adverse events during the study.
Time frame: 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).
Time frame: 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.
Time frame: up to 8 weeks (treatments period)
| Milestone | Tixel Treatment |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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.
| percentage change | Tixel Treatment |
|---|---|
| Efficacy of Tixel for Treatment of Actinic Keratosis | -90.4 ± 14.7 |
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.
| Number of lesions counted | Tixel Treatment |
|---|---|
| Baseline - Total No. of leasions counted | 10.0 ± 9.7 |
| 4 weeks FU - Total No. of lesions counted -Change from Baseline | 8.1 ± 6.8 |
| 12 weeks FU - Total No. of lesions counted -Change from Baseline | 8.5 ± 6.9 |
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.
| percentage change | Tixel Treatment |
|---|---|
| Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis | -83.6 ± 16.9 |
* 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.
| Participants | Tixel Treatment |
|---|---|
| 0-25% | 0 |
| 26-50% | 1 |
| 51-75% | 1 |
| 76-99% | 8 |
| 100% | 10 |
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).
| Participants | Tixel Treatment |
|---|---|
| I am satisfied with the results of the treatment (Improvement Assessment) — Excellent - Very satisfied (score 5) | 19 |
| I am satisfied with the results of the treatment (Improvement Assessment) — Good - Satisfied (score 4) | 1 |
| I am satisfied with the results of the treatment (Improvement Assessment) — Moderately - satisfied (score 3) | 0 |
| I am satisfied with the results of the treatment (Improvement Assessment) — Fair - Satisfied to some extent (score 2) | 0 |
| I am satisfied with the results of the treatment (Improvement Assessment) — Poor - Poor or not satisfied at all (score 1) | 0 |
| I am satisfied with the treatment experience — Excellent - Very satisfied (score 5) | 19 |
| I am satisfied with the treatment experience — Good - Satisfied (score 4) | 1 |
| I am satisfied with the treatment experience — Moderately - satisfied (score 3) | 0 |
| I am satisfied with the treatment experience — Fair - Satisfied to some extent (score 2) | 0 |
| I am satisfied with the treatment experience — Poor - Poor or not satisfied at all (score 1) | 0 |
| The treatment has fulfilled my expectations — Excellent - Very satisfied (score 5) | 16 |
| The treatment has fulfilled my expectations — Good - Satisfied (score 4) | 4 |
| The treatment has fulfilled my expectations — Moderately - satisfied (score 3) | 0 |
| The treatment has fulfilled my expectations — Fair - Satisfied to some extent (score 2) | 0 |
| The treatment has fulfilled my expectations — Poor - Poor or not satisfied at all (score 1) | 0 |
Procedure-related Adverse events during the study.
| Participants | Tixel Treatment |
|---|---|
| Safety Evaluation - Adverse Events | 0 |
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).
| Hours | Tixel Treatment |
|---|---|
| Follow-Up & Treatment 2. Time until return to work | 1.7 ± 5.7 |
| Follow-Up & Treatment 2. Time until return to Social activities | 1.4 ± 5.5 |
| Follow-Up & Treatment 2. Sensasion of heat | 7.8 ± 19.6 |
| Follow-Up & Treatment 2.Redness | 44.3 ± 48.7 |
| Follow-Up & Treatment 2. Edema | 10.7 ± 22.9 |
| Follow-Up & Treatment 2. Scabs | 40.4 ± 81.6 |
| Follow-Up & Treatment 3. Time until return to work | 1.4 ± 5.5 |
| Follow-Up & Treatment 3. Time until return to Social activities | 4.1 ± 12.0 |
| Follow-Up & Treatment 3. Sensation of heat | 0.7 ± 2.8 |
| Follow-Up & Treatment 3.Redness | 33.4 ± 55.2 |
| Follow-Up & Treatment 3. Edema | 1.3 ± 5.5 |
| Follow-Up & Treatment 3. Scabs | 54.2 ± 93.6 |
| 4 weeks FU Time until return to work | 0.1 ± 0.4 |
| 4 weeks FU Time until return to Social activities | 0.2 ± 0.7 |
| 4 weeks FU sensation of heat | 1.5 ± 5.3 |
| 4 weeks FU Redness | 36.1 ± 36.1 |
| 4 weeks FU Edema | 2.5 ± 7.4 |
| 4 weeks FU Scabs | 36.0 ± 59.0 |
Procedure related pain by the subjects using VAS for pain of 0-10 where a higher score indicates greater pain.
| score on a scale | Tixel Treatment |
|---|---|
| mean procedure-associated VAS scores - treatment 1 | 2.0 ± 2.0 |
| mean procedure-associated VAS scores - treatment 2 | 1.9 ± 1.7 |
| mean procedure-associated VAS scores - treatment 3 | 1.7 ± 1.7 |
Collected over Adverse event data were collected from the initiation of the treatment until the end of the study period, and a total duration of 12 weeks of FU completion.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tixel Treatment | 0/20 (0%) | 0/20 (0%) | 1/20 (5%) |
| Event | Tixel Treatment |
|---|---|
| DiarrheaGastrointestinal disorders | 1/20 |
| AstheniaGeneral disorders | 1/20 |
| Squamous Cell CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/20 |
A total of 20 subjects were enrolled in the study. All subjects were included in the PP population. All subjects received the full treatment sessions and had photos from the 12-week FU visit and therefore, completed the study.
| Age, Continuous(years) | Tixel Treatment |
|---|---|
| Mean | 67.7 ± 9.1 |
| Sex: Female, Male(Participants) | Tixel Treatment |
|---|---|
| Female | 8 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | Tixel Treatment |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 20 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Tixel Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Tixel Treatment |
|---|---|
| Israel | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2022 to primary completion in Sep 2023, 15 months.
Results were first posted in Dec 2024, 1 year 2 months after primary completion.
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 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novoxel Ltd.