Trials / Completed
CompletedNCT03366194
The Clinical Efficacy And Safety Of SkinStylus Microneedling System
The Clinical Efficacy And Safety Of SkinStylus Microneedling System for Ventral Torso Hypertrophic Scars: Clinical Results With 30 Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Esthetic Education LLC · Industry
- Sex
- All
- Age
- 23 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SkinStylus Sterilock System | Microneedling device will be used to treat ventral hypertrophic scars. |
Timeline
- Start date
- 2017-11-15
- Primary completion
- 2018-11-01
- Completion
- 2018-12-01
- First posted
- 2017-12-08
- Last updated
- 2022-05-11
- Results posted
- 2022-05-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03366194. Inclusion in this directory is not an endorsement.