The Clinical Efficacy And Safety Of SkinStylus Microneedling System

Esthetic Education LLC

Status: Completed

Conditions: Cicatrix, Hypertrophic

Treatments: Device: SkinStylus Sterilock System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03366194

20172466 2017-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 23+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Experimental

Experimental group

Description:

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.

Treatment:

Device: SkinStylus Sterilock System