Clinical trial NCT02297321: Evaluation of the Safety and Efficacy of the DeScribe™ Patch
Official title: Evaluation of the Safety and Efficacy of the DeScribe™ Laser Tattoo Removal Accessory Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tattoos
Keywords: tattoos
laser
whitening
patch
Lead sponsor: ON Light Sciences
Sponsor class: INDUSTRY
First posted: 2014-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of passes with Describe patch
timeFrame: 5 minutes
Secondary outcomes:
measure: Safety assessment: Overall rate and severity of all reported adverse events
timeFrame: immediate post treatment, 1-month post tx
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Nashville Centre for Laser and Facial Surgery
state: Tennessee
Study officials:
affiliation: Nashville Centre for Laser and Facial Surgery
name: Brian Biesman, MD
role: PRINCIPAL_INVESTIGATOR
References: