Status:
COMPLETED
Evaluation of the Safety and Efficacy of the DeScribe™ Patch
Lead Sponsor:
ON Light Sciences
Conditions:
Tattoos
Eligibility:
All Genders
18-90 years
Phase:
NA
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02297321
Start Date
November 1 2014
End Date
April 1 2015
Last Update
September 20 2016
Active Locations (1)
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1
Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, United States, 37203