NCT04527653

Evaluation of The Efficacy and Safety of Tixel Treatment for the Treatment of Facial and/or Scalp Actinic Keratoses

Evaluation of the Efficacy and Safety of a Thermal Fractional Skin Rejuvenation System (Tixel) for the Treatment of Facial and/or Scalp Actinic Keratoses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Novoxel Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 their clinical improvement), 3-4 weeks apart. Follow-up visits after the last treatment visit: 4 weeks (±7 days), 12 weeks (±7 days), 52 weeks (±14 days) - the last follow up visit is a voluntary one. The inclusion criteria would be mild to moderate thickness confluent actinic keratoses located to scalp and/or face.

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
DEVICE	Tixel	Non-invasive thermo-mechanical treatment

Timeline

• Start date: 2020-05-14
• Primary completion: 2021-04-19
• Completion: 2021-04-19
• First posted: 2020-08-26
• Last updated: 2021-06-04

Locations

1 site across 1 country: Israel