Evaluation of the Safety and Efficacy of the DeScribe™ Patch

ON Light Sciences

Status

Completed

Conditions

Tattoos

Treatments

Device: Describe patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT02297321

DeScribe-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.