Evaluation of the Safety and Efficacy of the DeScribe™ Patch

NCT02297321 | Completed

• 1 other identifier: DeScribe-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tattoos

Keywords

tattoos; laser; whitening; patch

Outcome Measures

Primary Outcomes (1)

• Number of passes with Describe patch

  Number of passes with Describe patch compared to laser only

  5 minutes

Secondary Outcomes (1)

• Safety assessment: Overall rate and severity of all reported adverse events

  immediate post treatment, 1-month post tx

Study Arms (1)

DeScribe patch

EXPERIMENTAL

Comparison of the number of passes achieved using the Describe patch plus laser compared to laser along

Device: Describe patch

Interventions

Describe patch DEVICE

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

DeScribe patch

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ON Light Sciences: lead

Study Sites (1)

Nashville Centre for Laser and Facial Surgery

Nashville, Tennessee, 37203, United States

Location

Study Officials

• Brian Biesman, MD

  Nashville Centre for Laser and Facial Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 21, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 20, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)