A Prospective, Single-center, Single-arm Clinical Study Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Photodamage at Low Settings
Status: Unknown
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To demonstrate the safety and performance of the Tixel fractional system for treatment of photodamage using low-energy settings.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 70
Healthy Volunteers: t
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• Male or female 25-70 years old with clinically evident photodamage.
• Willingness and ability to comply with all required study activities including returning for follow-up visits and protocol requirements.
• The subject is able to provide written informed consent and perform the study's activities according to HIPAA guidelines.
• Fitzpatrick wrinkle score of 3-7 in the per the treating investigator and clinically noticeable wrinkles in the treating area.
• Skin Type I - V as per Fitzpatrick Skin Scale.
Locations
United States
Pennsylvania
Main Line Center for Laser Surgery
Ardmore
Time Frame
Start Date: 2022-01-07
Completion Date: 2023-12
Participants
Target number of participants: 25
Treatments
Experimental: Tixel treatment arm
subjects will receive 3 monthly treatments with the Tixel device
Authors
Sponsors
Leads: Eric Bernstein, MD
Collaborators: Novoxel Ltd.