Tattoos
Conditions
Keywords
tattoos, laser, whitening, patch
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.
Interventions
DEVICEDescribe patch
Application of Describe patch over tattoo for approximately 5 minutes during Q-switched laser treatment
Sponsors
ON Light Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of passes with Describe patch | 5 minutes | Number of passes with Describe patch compared to laser only |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment: Overall rate and severity of all reported adverse events | immediate post treatment, 1-month post tx | Overall rate and severity of all reported adverse events |
Countries
United States
Outcome results
None listed