Evaluation of the Safety and Efficacy of the DeScribe™ Patch

Evaluation of the Safety and Efficacy of the DeScribe™ Laser Tattoo Removal Accessory Device

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.

Study Overview

• Status: Completed
• Conditions: Tattoos
• Intervention / Treatment: Device: Describe patch

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Nashville Centre for Laser and Facial Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DeScribe patch; Comparison of the number of passes achieved using the Describe patch plus laser compared to laser along	Device: Describe patch; Application of Describe patch over tattoo for approximately 5 minutes during Q-switched laser treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of passes with Describe patch	Number of passes with Describe patch compared to laser only	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessment: Overall rate and severity of all reported adverse events	Overall rate and severity of all reported adverse events	immediate post treatment, 1-month post tx

Collaborators and Investigators

• Sponsor: ON Light Sciences
• Investigators: Principal Investigator: Brian Biesman, MD, Nashville Centre for Laser and Facial Surgery

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: November 13, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 21, 2014

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 16, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: patch; laser; whitening; tattoos
• Other Study ID Numbers: DeScribe-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO