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

Last updated: November 26, 2024
Sponsor: Novoxel Ltd.
Overall Status: Completed

Phase

N/A

Condition

Keratoses

Treatment

Tixel C

Clinical Study ID

NCT05365386
CLN 0827
  • Ages 18-80
  • All Genders

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

Eligibility Criteria

Inclusion

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 studyvisits.

  5. Subject has provided written informed consent.

Exclusion

Exclusion Criteria:

  1. Any patient who has undergone tanning during the 4 weeks prior to any treatmentsession and/or any patient who plans to undergo tanning during the 4 weeks followingany treatment session (patients who may be exposed to the sun for short periods oftime occasionally are not contra-indicated as long as they apply a high SPFsunscreen (>50).

  2. Current active Herpes Simplex infection.

  3. Current skin cancer, malignant sites and/or advanced premalignant lesions or molesin 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 topicalapplication), herbal treatment (oral or topic), food supplements or vitamins, whichmay 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 skinin any of the areas to be treated.

  11. Women who are pregnant (as determined by self-reporting), lactating, or less than 3months post-delivery, possibly pregnant or planning a pregnancy during the studyperiod.

  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 monthsprior to enrollment.

  14. Any cryotherapy or electrodessication 6 weeks prior to enrollment.

  15. Systemic retinoid therapy within 6 months prior to enrollment, topical treatmentwith 5-Fluorouracil cream and/or imiquimod cream and/or diclofenac gel 6 monthsprior 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.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Tixel C
Phase:
Study Start date:
May 17, 2022
Estimated Completion Date:
September 12, 2023

Study 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).

Connect with a study center

  • Rabin Medical Center, Ha'Sharon Campus

    Petach Tikva, 49100
    Israel

    Site Not Available

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