N/A
Completed N=36
The Clinical Efficacy And Safety Of SkinStylus Microneedling System
Cicatrix, Hypertrophic
Source: ClinicalTrials.gov NCT03366194 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Number of Participants With Improvement Assessed Using the VAS Scar Scoring System — 22 Participants
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.
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 | — |
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
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. Informational only — not medical advice.