N/A N=36 Treatment

The Clinical Efficacy And Safety Of SkinStylus Microneedling System

Cicatrix, Hypertrophic

Bottom Line

View on ClinicalTrials.gov: NCT03366194 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2022

Primary outcome: Primary: Number of Participants With Improvement Assessed Using the VAS Scar Scoring System — 22 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SkinStylus Sterilock System (Device)
Age: Adult, Older Adult · 23+ yrs
Sex: All
Sponsor: Esthetic Education LLC
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Improvement Assessed Using the VAS Scar Scoring System	22	—
SECONDARY Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey	28	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03366194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.