Trials / Completed
CompletedNCT02297321
Evaluation of the Safety and Efficacy of the DeScribe™ Patch
Evaluation of the Safety and Efficacy of the DeScribe™ Laser Tattoo Removal Accessory Device
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- ON Light Sciences · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Accepted
Summary
This is a prospective study to evaluate the efficacy and safety of an accessory for laser tattoo removal in allowing multiple passes within a single treatment session.
Detailed description
This is a prospective study to evaluate the efficacy and safety of an accessory for laser tattoo removal in allowing multiple passes within a single treatment session. One half of the tattoo will be randomly assigned laser treatment utilizing the Device (the "Device half"); the other half will receive laser treatment without the Device and serve as the control (the "Control half"). Based on statistical analysis sample size calculations, 30 subjects will be enrolled. The tattoo must be no larger than approximately 2 ½" x 6" or 3" x 5" in size, such that ½ of the tattoo can be covered with a single patch. Each subject will receive a single Treatment Session consisting of 5 minutes. Investigators will administer the standard laser treatment to both the Device and Control sites using well-established tattoo-removal treatment parameters for the laser used. Subjects will return for follow up approximately one month post-treatment. The presence of side effects and adverse events will be assessed and recorded for both Device and Control sites immediately after treatment and at the 1-month follow-up visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Describe patch | Application of Describe patch over tattoo for approximately 5 minutes during Q-switched laser treatment |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2015-01-01
- Completion
- 2015-04-01
- First posted
- 2014-11-21
- Last updated
- 2016-09-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02297321. Inclusion in this directory is not an endorsement.