CompletedNot Applicable

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

Israel20 participantsStarted 2022-05-17

Plain-language 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

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Male and female, age 18-80 years old.
✓. Skin Phototype I-VI.
✓. Subject has mild to moderate thickness confluent AKs on his/her scalp and/or face.
✓. Subject is willing and able to comply with protocol requirements and all study visits.
✓. Subject has provided written informed consent.

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 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.
✕. Any patient who has used oral retinoids within 6 months prior to treatment or less.
✕. Any patient who has a history of bleeding coagulopathies.

What they're measuring

Efficacy of Tixel for Treatment of Actinic Keratosis

Timeframe: up to 12 weeks post last treatment

Trial details

NCT IDNCT05365386

SponsorNovoxel Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-12

Results submitted2024-05-26

View on ClinicalTrials.gov More Actinic Keratoses trials