The purpose of the trial is to provide objective evidence the SkinStylus may be used safely and effectively for the treatment of ventral torso hypertrophic scars.
1. The SkinStylus has been designated as a non-significant risk and therefore will be granted an Investigational Device Exemption (IDE). There are no meaningful changes to the SkinStylus® instructions for use and specifically no new risks will be introduced. 2. Each participant shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. At the conclusion of the trial all participants shall be provided with a cross over treatment on the non-treated portion of the scar identical to that which was provided within the trial for the purpose of "evening" the ventral torso hypertrophic scar. This is entirely voluntary and participants may decline the treatment if they wish.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Microneedling device will be used to treat ventral hypertrophic scars.
Esthetic Education LLC
Scottsdale, Arizona, United States
Number of Participants With Improvement Assessed Using the VAS Scar Scoring System
The Visual Analog Scale Scar Scoring System (VAS Scar Scale) is a validated scar assessment scale with a minimum scar improvement value of 0.0 cm on one end of a 10.0 cm long line and 10.0 cm on the other end. The 0.0 cm represents "no change" in the appearance of the scar while 10.0 cm represents "complete resolution" of the scar. A panel of 3 expert graders viewed images of the treatment area and the control area before treatment and 90 days after the last treatment. The difference between the measurements taken at baseline and measurements taken two weeks following the end of the treatment of the treatment area was calculated for each participant, for each grader. The difference of all three graders analysis for each subject was averaged. Those participants with a VAS score on the treatment side that met the MCID of an improvement of at least 1.0 cm were identified in the results as "responders". A higher score is a better outcome.
Time frame: 90 days from date of last treatment
Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey
The Self-Assessed Scar Improvement Scale is a validated 6-point scale (-1 to 4) describing the patient's opinion regarding the overall improvement of the scar after treatment with "4" constituting the patient believing that the scar had a "75%-99%" improvement, "3" constituting a "50%-75%" improvement, "2" constituting a "25%-50%" improvement, "1" constituting a "1%-25%" improvement, "0" constituting "no change", and "-1" constituting an "exacerbation of the scar's appearance". A higher score means a better outcome.
Time frame: 90 days from date of last treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.