Actinic Keratoses
Conditions
Keywords
actinic keratoses.
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 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).
Interventions
DEVICETixel C
This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
Sponsors
Novoxel Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-center, Prospective, Open Label, with Before-After Study Design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female, age 18-80 years old. 2. Skin Phototype I-VI. 3. Subject has mild to moderate thickness confluent AKs on his/her scalp and/or face. 4. Subject is willing and able to comply with protocol requirements and all study visits. 5. Subject has provided written informed consent.
Exclusion criteria
1. 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). 2. Current active Herpes Simplex infection. 3. Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area. 4. An impaired immune system condition or use of immunosuppressive medication. 5. Collagen disorders, keloid formation and/or abnormal wound healing. 6. 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. 7. Any patient who has used oral retinoids within 6 months prior to treatment or less. 8. Any patient who has a history of bleeding coagulopathies. 9. Any patient who has tattoos or permanent makeup in the treated area. 10. Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated. 11. 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. 12. Currently participating in or recently participated in another clinical trial (within the last 30 days). 13. Prior treatment with ablative laser, any laser or photo-dynamic therapy 3 months prior to enrollment. 14. Any cryotherapy or electrodessication 6 weeks prior to enrollment. 15. 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. 16. Prior treatment with Tixel. 17. Face cannot be treated due to dermal disorder other than AKs, such as infection, surgical treatment etc. 18. Subject has a systemic disease manifested by AKs (e.g. immune suppression). 19. Significant systemic illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Tixel for Treatment of Actinic Keratosis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | up to 12 weeks post 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. |
| To Evaluate the Subject's Satisfaction. | up to 12 weeks post last treatment | 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). |
| Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis | up to 12 weeks post last treatment | 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. |
| Subject Subjective Downtime Assessment | up to 4 weeks post last treatment | 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). |
| VAS Assessment | up to 8 weeks (treatments period) | Procedure related pain by the subjects using VAS for pain of 0-10 where a higher score indicates greater pain. |
| Safety Evaluation - Adverse Events | up to 12 weeks post last treatment | Procedure-related Adverse events during the study. |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tixel Treatment All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart with the Tixel device.
Tixel C: This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Tixel Treatment |
|---|---|
| Age, Continuous | 67.7 years STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment Israel | 20 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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
Population: per protocol population - subject lesion count change from baseline % at 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tixel Treatment | Efficacy of Tixel for Treatment of Actinic Keratosis | -90.4 percentage change | Standard Deviation 14.7 |
Secondary
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
Population: per protocol population - subject lesion count change from baseline at 4 and 12 weeks FU
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tixel Treatment | Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis | Baseline - Total No. of leasions counted | 10.0 Number of lesions counted | Standard Deviation 9.7 |
| Tixel Treatment | Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis | 4 weeks FU - Total No. of lesions counted -Change from Baseline | 8.1 Number of lesions counted | Standard Deviation 6.8 |
| Tixel Treatment | Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis | 12 weeks FU - Total No. of lesions counted -Change from Baseline | 8.5 Number of lesions counted | Standard Deviation 6.9 |
Secondary
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
Population: per protocol population - subject lesion count change from baseline % at 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tixel Treatment | Efficacy Evaluation of Tixel for Treatment of Actinic Keratosis | -83.6 percentage change | Standard Deviation 16.9 |
Secondary
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
Population: Lesion count - relative change from baseline (by category)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tixel 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. | 0-25% | 0 Participants |
| Tixel 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. | 26-50% | 1 Participants |
| Tixel 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. | 51-75% | 1 Participants |
| Tixel 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. | 76-99% | 8 Participants |
| Tixel 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. | 100% | 10 Participants |
Secondary
Safety Evaluation - Adverse Events
Procedure-related Adverse events during the study.
Time frame: up to 12 weeks post last treatment
Population: safety population - Procedure-related Adverse Events reported
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tixel Treatment | Safety Evaluation - Adverse Events | 0 Participants |
Secondary
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
Population: Downtime was assessed at the FU visits post treatments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tixel Treatment | Subject Subjective Downtime Assessment | Follow-Up & Treatment 2. Time until return to work | 1.7 Hours | Standard Deviation 5.7 |
| Tixel Treatment | Subject Subjective Downtime Assessment | Follow-Up & Treatment 2. Time until return to Social activities | 1.4 Hours | Standard Deviation 5.5 |
| Tixel Treatment | Subject Subjective Downtime Assessment | Follow-Up & Treatment 2. Sensasion of heat | 7.8 Hours | Standard Deviation 19.6 |
| Tixel Treatment | Subject Subjective Downtime Assessment | Follow-Up & Treatment 2.Redness | 44.3 Hours | Standard Deviation 48.7 |
| Tixel Treatment | Subject Subjective Downtime Assessment | Follow-Up & Treatment 2. Edema | 10.7 Hours | Standard Deviation 22.9 |
| Tixel Treatment | Subject Subjective Downtime Assessment | Follow-Up & Treatment 2. Scabs | 40.4 Hours | Standard Deviation 81.6 |
| Tixel Treatment | Subject Subjective Downtime Assessment | Follow-Up & Treatment 3. Time until return to work | 1.4 Hours | Standard Deviation 5.5 |
| Tixel Treatment | Subject Subjective Downtime Assessment | Follow-Up & Treatment 3. Sensation of heat | 0.7 Hours | Standard Deviation 2.8 |
| Tixel Treatment | Subject Subjective Downtime Assessment | Follow-Up & Treatment 3. Edema | 1.3 Hours | Standard Deviation 5.5 |
| Tixel Treatment | Subject Subjective Downtime Assessment | Follow-Up & Treatment 3. Scabs | 54.2 Hours | Standard Deviation 93.6 |
| Tixel Treatment | Subject Subjective Downtime Assessment | 4 weeks FU Time until return to work | 0.1 Hours | Standard Deviation 0.4 |
| Tixel Treatment | Subject Subjective Downtime Assessment | 4 weeks FU Time until return to Social activities | 0.2 Hours | Standard Deviation 0.7 |
| Tixel Treatment | Subject Subjective Downtime Assessment | 4 weeks FU sensation of heat | 1.5 Hours | Standard Deviation 5.3 |
| Tixel Treatment | Subject Subjective Downtime Assessment | 4 weeks FU Redness | 36.1 Hours | Standard Deviation 36.1 |
| Tixel Treatment | Subject Subjective Downtime Assessment | 4 weeks FU Scabs | 36.0 Hours | Standard Deviation 59 |
| Tixel Treatment | Subject Subjective Downtime Assessment | Follow-Up & Treatment 3. Time until return to Social activities | 4.1 Hours | Standard Deviation 12 |
| Tixel Treatment | Subject Subjective Downtime Assessment | Follow-Up & Treatment 3.Redness | 33.4 Hours | Standard Deviation 55.2 |
| Tixel Treatment | Subject Subjective Downtime Assessment | 4 weeks FU Edema | 2.5 Hours | Standard Deviation 7.4 |
Secondary
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
Population: per protocol population - Experience questionnaire completed by the subjects
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tixel Treatment | To Evaluate the Subject's Satisfaction. | I am satisfied with the results of the treatment (Improvement Assessment) | Excellent - Very satisfied (score 5) | 19 Participants |
| Tixel Treatment | To Evaluate the Subject's Satisfaction. | I am satisfied with the results of the treatment (Improvement Assessment) | Good - Satisfied (score 4) | 1 Participants |
| Tixel Treatment | To Evaluate the Subject's Satisfaction. | I am satisfied with the results of the treatment (Improvement Assessment) | Moderately - satisfied (score 3) | 0 Participants |
| Tixel Treatment | To Evaluate the Subject's Satisfaction. | I am satisfied with the results of the treatment (Improvement Assessment) | Fair - Satisfied to some extent (score 2) | 0 Participants |
| Tixel Treatment | To Evaluate the Subject's Satisfaction. | I am satisfied with the results of the treatment (Improvement Assessment) | Poor - Poor or not satisfied at all (score 1) | 0 Participants |
| Tixel Treatment | To Evaluate the Subject's Satisfaction. | I am satisfied with the treatment experience | Excellent - Very satisfied (score 5) | 19 Participants |
| Tixel Treatment | To Evaluate the Subject's Satisfaction. | I am satisfied with the treatment experience | Good - Satisfied (score 4) | 1 Participants |
| Tixel Treatment | To Evaluate the Subject's Satisfaction. | I am satisfied with the treatment experience | Moderately - satisfied (score 3) | 0 Participants |
| Tixel Treatment | To Evaluate the Subject's Satisfaction. | I am satisfied with the treatment experience | Fair - Satisfied to some extent (score 2) | 0 Participants |
| Tixel Treatment | To Evaluate the Subject's Satisfaction. | I am satisfied with the treatment experience | Poor - Poor or not satisfied at all (score 1) | 0 Participants |
| Tixel Treatment | To Evaluate the Subject's Satisfaction. | The treatment has fulfilled my expectations | Excellent - Very satisfied (score 5) | 16 Participants |
| Tixel Treatment | To Evaluate the Subject's Satisfaction. | The treatment has fulfilled my expectations | Fair - Satisfied to some extent (score 2) | 0 Participants |
| Tixel Treatment | To Evaluate the Subject's Satisfaction. | The treatment has fulfilled my expectations | Poor - Poor or not satisfied at all (score 1) | 0 Participants |
| Tixel Treatment | To Evaluate the Subject's Satisfaction. | The treatment has fulfilled my expectations | Good - Satisfied (score 4) | 4 Participants |
| Tixel Treatment | To Evaluate the Subject's Satisfaction. | The treatment has fulfilled my expectations | Moderately - satisfied (score 3) | 0 Participants |
Secondary
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)
Population: The mean procedure-associated VAS scores reported by the subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tixel Treatment | VAS Assessment | mean procedure-associated VAS scores - treatment 1 | 2.0 score on a scale | Standard Deviation 2 |
| Tixel Treatment | VAS Assessment | mean procedure-associated VAS scores - treatment 2 | 1.9 score on a scale | Standard Deviation 1.7 |
| Tixel Treatment | VAS Assessment | mean procedure-associated VAS scores - treatment 3 | 1.7 score on a scale | Standard Deviation 1.7 |