Evaluation of the Safety and Efficacy of the DeScribeâ„¢ Patch (NCT02297321) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Safety and Efficacy of the DeScribeâ„¢ Patch
United States30 participantsStarted 2014-11
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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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.