Evaluation of the Safety and Efficacy of the DeScribe™ Patch

Not Applicable

Completed

• Conditions: Tattoos
• Interventions: Device: Describe patch

• Registration Number: NCT02297321
• Lead Sponsor: ON Light Sciences

Brief 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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-21
• Primary Completion: 2015-01
• Study Completion: 2015-04
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-16
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Subjects presenting with tattoos approximately 2 ½" x 6" or 3" x 5" or smaller in size.
• Fitzpatrick skin type I - III
• Women of childbearing potential using an accepted form of contraception at least 3 months prior to enrollment and during the study period (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence)
• Subjects who provide written informed consent
• Subjects who agree to all treatment guidelines and follow-up visits

Exclusion Criteria

• Subjects younger than 18 years of age
• Subjects with traumatic tattoos
• As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in the study
• Subjects who are pregnant or breastfeeding
• Subjects who are tan
• As per the investigator's discretion, subjects with a history of keloid scarring or abnormal wound healing
• Subjects who have used oral retinoids (isotretinoin or acitretin) within 12 months of study entry
• Subjects currently participating or planning to participate in any other clinical trial specifically designed to treat tattoos during the course of this study and for the duration of their participation in the study
• Subjects who refuse to sign this informed consent form and/or refuse to comply with all study requirements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DeScribe patch	Describe patch	Comparison of the number of passes achieved using the Describe patch plus laser compared to laser along

Primary Outcome Measures

Name	Time	Method
Number of passes with Describe patch	5 minutes	Number of passes with Describe patch compared to laser only

Secondary Outcome Measures

Name	Time	Method
Safety assessment: Overall rate and severity of all reported adverse events	immediate post treatment, 1-month post tx	Overall rate and severity of all reported adverse events

Trial Locations

Locations (1)

Nashville Centre for Laser and Facial Surgery; 🇺🇸 Nashville, Tennessee, United States