Evaluation of the Safety and Efficacy of the DeScribe™ Patch

Tattoos Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297321
• Other study ID #: DeScribe-01
• Status: Completed
• Phase: N/A
• First received: November 13, 2014
• Last updated: September 16, 2016
• Start date: November 2014
• Est. completion date: April 2015

Study information

• Verified date: September 2016
• Source: ON Light Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Tattoos

Intervention

Device:
• Describe patch
Application of Describe patch over tattoo for approximately 5 minutes during Q-switched laser treatment

Locations

Country	Name	City	State
United States	Nashville Centre for Laser and Facial Surgery	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
ON Light Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of passes with Describe patch	Number of passes with Describe patch compared to laser only	5 minutes	Yes
Secondary	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	Yes