The Clinical Efficacy And Safety Of SkinStylus Microneedling System

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

at least 23 years old
shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs.
The scar(s) must present along a flat surface suitable for application of the SkinStylus® device and consistent medical photography.

Exclusion Criteria

Pregnancy or chance of pregnancy
Currently taking Coumadin/Warfarin® or heparin
Diagnosis of any type of bleeding disorder
Any history of keloid formation
Lidocaine, tetracaine, prilocaine, bupivacaine, or benzocaine hypersensitivity
Diagnosis of mental disorders requiring inpatient treatment
Presence of metal implants around the proposed treatment areas
Diagnosis of any undefined wasting disease (Cachexia for example)
Diagnosis of an active infection in the treatment area other than mild acne
Diagnosis of the presence of tumors or those who are being treated by chemotherapy or radiation therapy
Diagnosis of severe cardiovascular and cerebrovascular disease
Diagnosis of renal failure

Arm && Interventions

Group	Intervention	Description
Experimental	SkinStylus Sterilock System	Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Improvement Assessed Using the VAS Scar Scoring System	90 days from date of last treatment	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey	90 days from date of last treatment	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.