Clinical Study to Evaluate the Safety and Effectiveness of the Treatment With Tixel C on Acne Scars
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|ClinicalTrials.gov Identifier: NCT04269317|
Recruitment Status : Withdrawn (Delay in opening the study due to COVID-19, and following the sponsor's decision)
First Posted : February 13, 2020
Last Update Posted : January 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Scars||Device: Tixel C||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Blinded assessed of the improvement would be done between Last FU images and before first treatment after randomization of the images.|
|Official Title:||A Prospective Study With Blinded Assessment to Evaluate the Safety and Effectiveness of the Tixel C Fractional System in the Treatment of Acne Scars|
|Estimated Study Start Date :||March 1, 2020|
|Actual Primary Completion Date :||January 10, 2021|
|Actual Study Completion Date :||January 10, 2021|
Experimental: Tixel C
Tixel Treatment, between 3-5 treatment session according to investigator's review of subject response follow by 3 Follow up sessions, 1,3 and 6 month after last treatment visit. Subject would be questioned about pain levvel, subjective dountime assessment and subjective response assessment. Images would be taken before treatment visit and in Follow-Up.
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.
Other Name: Fractional
- Safety Adverse Events report [ Time Frame: up to 12 months ]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.
- Effectiveness using Goodman and Baron Assessment scale [ Time Frame: up to 12 months; Improvement between last follow up and baseline (before first treatment) ]
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
- Performance using Goodman and Baron Assessment scale [ Time Frame: up to 12 months; Improvement between last follow up and baseline (before first treatment) ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269317
|United States, Illinois|
|Physicians Laser and Dermatology Institute|
|Chicago, Illinois, United States, 60611|
|The Lehavit Akerman Main Clinic|
|Herzliya, Israel, 4672553|
|Principal Investigator:||Jerome M Garden, MD||Physicians Laser and Dermatology Institute|