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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
Physicians Laser and Dermatology Institute
Chicago, Illinois, United States
The Lehavit Akerman Main Clinic
Herzliya, Israel
Safety Adverse Events report
Safety of the investigational device shall be assessed via quantification of the incidence of devicerelated/non-related undesired effects, which shall be documented and reported as an Adverse Event (AE) or as a Serious Adverse Event (SAE). Known undesired effects may be any of the list stated in the previous paragraph of Expected Possible Side Effects, or any other undesired effect, not described in the said list. The incidence of the device related undesired effects should be analyzed considering severity, causal relation to the investigational device and duration, whether it is transient or permanent.
Time frame: up to 12 months
Effectiveness using Goodman and Baron Assessment scale
Before starting therapy and at one and six months follow up visits, the subjects shall be photographed using clinical photography equipment. The images shall be evaluated by blinded raters. The evaluation shall be performed by three raters. The scores shall be analyzed according to the statistical plan of the study. Scale between 1-4; 1 = Macular, 4= Severe
Time frame: up to 12 months; Improvement between last follow up and baseline (before first treatment)
Performance using Goodman and Baron Assessment scale
Live Assessment by a study investigator - In each visit, an investigator or his designee shall examine by observing the subject and photographs will be taken as outlined. Scale between 1-4; 1 = Macular, 4= Severe
Time frame: up to 12 months; Improvement between last follow up and baseline (before first treatment)
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