NCT04269317

Clinical Study to Evaluate the Safety and Effectiveness of the Treatment With Tixel C on Acne Scars

A Prospective Study With Blinded Assessment to Evaluate the Safety and Effectiveness of the Tixel C Fractional System in the Treatment of Acne Scars

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novoxel Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research is to evaluate the safety and effectiveness of the Tixel C device for the treatment of acne scars, for improvement in the appearance of surface texture.

Detailed description

44 participents between two research locations with moderate acne scars will receive 3-5 treatments sessions with the Tixel C device according to investigator's review of subject response. Improvement of acne scarring will ve evaluated at 1 month, 3 months and 6 months post treatment. Post-treatment response will be evaluated as well as any incidence of side efects throughout the study.

Conditions

• Scars

Interventions

Type	Name	Description
DEVICE	Tixel C	Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide for dermal remodeling and collagen restructuring that promote acne scar appearance improvement.

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-01-10
• Completion: 2021-01-10
• First posted: 2020-02-13
• Last updated: 2021-01-12

Locations

2 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated device study