The Clinical Efficacy And Safety Of SkinStylus Microneedling System

NCT03366194 | Completed Results FDA Device

• 1 other identifier: 20172466 2017-002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cicatrix, Hypertrophic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  90 days from date of last treatment

Study Arms (1)

Experimental

EXPERIMENTAL

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

Interventions

SkinStylus Sterilock System DEVICE

Microneedling device will be used to treat ventral hypertrophic scars.

Experimental

Eligibility Criteria

• Age: 23 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Esthetic Education LLC: lead

Study Sites (1)

Esthetic Education LLC

Scottsdale, Arizona, 85260, United States

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Coordinator
• Organization: Esthetic Education LLC

Support@skinstylus.com

(480) 656-2251

Study Officials

• Toni Stockton, MD

  Principal Investigator for Esthetic Education LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 3\. The trial shall be blinded and bias minimized in that three (3) physicians who are either dermatologists or plastic surgeons (and not affiliated with the trial or Esthetic Education LLC) shall review the baseline and treatment photographs and score them using the VAS scale (Visual Analogue Scale).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 8, 2017
• Study Start: November 15, 2017
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 11, 2022
• Results First Posted: May 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)