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Efficacy and Safety of Tixel Treatment on Facial and/or Scalp Actinic Keratoses. | Clinical Trials | Clareo Health

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Efficacy and Safety of Tixel Treatment on 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.

NCT05365386•Novoxel Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.
+9 more criteria

Locations (1)

Rabin Medical Center, Ha'Sharon Campus

Petah Tikva, Israel

Key Dates

Start Date

May 17, 2022

Primary Completion Date

September 12, 2023

Completion Date

September 12, 2023

Last Updated

December 3, 2024

Enrollment

ACTUAL participants

Conditions

Actinic Keratoses

Interventions

Tixel C

DEVICE

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Tixel Treatment on Facial and/or Scalp Actinic Keratoses.

Inclusion Criteria

Exclusion Criteria

Investigation of the Effect of Lipikar Baume AP+M

SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography

Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis

Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia

The Influence of an E-learning Program on Recognition of Actinic Keratosis

Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses