Evaluation of the Safety and Efficacy of the DeScribe™ Patch

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tattoos

Intervention / Treatment
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* Device: Describe patch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DeScribe patch<br>Comparison of the number of passes achieved using the Describe patch plus laser compared to laser along | Device: Describe patch<br>* Application of Describe patch over tattoo for approximately 5 minutes during Q-switched laser treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of passes with Describe patch | Number of passes with Describe patch compared to laser only | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patch, tattoos, laser, whitening