Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo Removal (NCT01973166) | Clinical Trial Compass
CompletedNot Applicable
Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo Removal
United States42 participantsStarted 2013-09
Plain-language summary
The purpose of this study is to compare the investigational medical grade laser device to a marketed medical grade laser device for effectiveness in lightening or clearing unwanted tattoos. This study will also compare any side effects from treatment with the devices.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Females or Males, 18 to 65 years of age (inclusive)
* Fitzpatrick Skin Type I - IV (Appendix 3)
* Tattoos containing black/blue ink alone or in combination with other colors
* Target tattoos older than 1 year
* Presence of tattoos equal or greater than 2 square inches, not to exceed 12 square inches
* Must be able to read, understand and sign the Informed Consent Form
* Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions
* Wiling to cover tattoos with a bandage or clothing; and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area starting 2 to 4 weeks before the treatment and/or every day for the duration of the study, including the follow-up period
* Willing to use hydroquinone approximately 4 weeks pre-treatment and post- treatment if required
* Willingness to have digital photographs taken of the treated area
* Agree not to undergo any other procedure(s) for the tattoo removal during the study
* Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study
Exclusion Criteria:
* Participation in a study of another device or drug within 6 months prior to enrollment or during the study
* Prior treatment for tattoo removal in the target area, e.g., with q-switched laser, IPL, dermabrasion, electrocautery, cryotherapy
* History of a…
What they're measuring
1
Tattoo Clearing at 6 Weeks Post-final Laser Treatment for Each Treatment Arm as Assessed by Blinded Reviewers.