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CompletedNCT02297321Updated Sep 20, 2016

Evaluation of the Safety and Efficacy of the DeScribe™ Patch

An interventional study of Describe patch in Tattoos, sponsored by ON Light Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-20.

Sponsored by ON Light Sciences · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tattoos

Keywords

  • tattoos
  • laser
  • whitening
  • patch
03

In context

Lead sponsor

This is the only study on the registry with ON Light Sciences as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    DeScribe patch

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

    Device: Describe patch

Interventions

  • DeviceDescribe patch

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

06

What researchers measure

Primary outcomes

  1. Number of passes with Describe patch

    Number of passes with Describe patch compared to laser only

    Time frame: 5 minutes

Secondary outcomes

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

    Overall rate and severity of all reported adverse events

    Time frame: immediate post treatment, 1-month post tx

07

Study locations

1 site
  • Nashville Centre for Laser and Facial Surgery
    Nashville, Tennessee 37203, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02297321
Lead sponsor
ON Light Sciences
Responsible party
Sponsor
First posted
Nov 21, 2014
Start date
Nov 2014
Primary completion
Jan 2015
Completion
Apr 2015
Last update
Sep 20, 2016

Study contacts

Brian Biesman, MD
principal investigator · Nashville Centre for Laser and Facial Surgery

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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