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Completed

NCT Number: NCT03366194

The Clinical Efficacy And Safety Of SkinStylus Microneedling System

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.

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Key information

Conditions

Cicatrix, Hypertrophic Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

23 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Esthetic Education LLC

Scottsdale, Arizona, 85260, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SkinStylus Sterilock System

Device

Microneedling device will be used to treat ventral hypertrophic scars.

Primary outcomes

  1. Number of Participants With Improvement Assessed Using the VAS Scar Scoring System

    Time frame: 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 outcomes

  1. Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Esthetic Education LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 8, 2017
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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