The Clinical Efficacy And Safety Of SkinStylus Microneedling System

Study Overview
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Brief Summary
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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
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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. 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.

Official Title
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The Clinical Efficacy And Safety Of SkinStylus Microneedling System for Ventral Torso Hypertrophic Scars: Clinical Results With 30 Patients

Conditions
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Cicatrix, Hypertrophic

Intervention / Treatment
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* Device: SkinStylus Sterilock System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 23 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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. | Device: SkinStylus Sterilock System<br>* Microneedling device will be used to treat ventral hypertrophic scars.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 90 days from date of last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 90 days from date of last treatment |