The Clinical Efficacy And Safety Of SkinStylus Microneedling System

Cicatrix, Hypertrophic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03366194
• Other study ID #: 20172466 2017-002
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: April 2022
• Source: Esthetic Education LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Years and older

Eligibility

Inclusion Criteria:

1. at least 23 years old

2. shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs.

3. The scar(s) must present along a flat surface suitable for application of the SkinStylus® device and consistent medical photography.

Exclusion Criteria:

1. Pregnancy or chance of pregnancy

2. Currently taking Coumadin/Warfarin® or heparin

3. Diagnosis of any type of bleeding disorder

4. Any history of keloid formation

5. Lidocaine, tetracaine, prilocaine, bupivacaine, or benzocaine hypersensitivity

6. Diagnosis of mental disorders requiring inpatient treatment

7. Presence of metal implants around the proposed treatment areas

8. Diagnosis of any undefined wasting disease (Cachexia for example)

9. Diagnosis of an active infection in the treatment area other than mild acne

10. Diagnosis of the presence of tumors or those who are being treated by chemotherapy or radiation therapy

11. Diagnosis of severe cardiovascular and cerebrovascular disease

12. Diagnosis of renal failure

Related Conditions & MeSH terms

• Cicatrix
• Cicatrix, Hypertrophic
• Hypertrophy

Intervention

Device:
• SkinStylus Sterilock System
Microneedling device will be used to treat ventral hypertrophic scars.

Locations

Country	Name	City	State
United States	Esthetic Education LLC	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Esthetic Education LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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