Comparison Study of Picosecond and Nanosecond Pulse Durations Using a Q-switched Nd:YAG Laser for… (NCT02244554) | Clinical Trial Compass
CompletedNot Applicable
Comparison Study of Picosecond and Nanosecond Pulse Durations Using a Q-switched Nd:YAG Laser for Tattoo Removal
United States10 participantsStarted 2014-07
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of laser tattoo removal with picosecond pulse durations as compared to treatment with nanosecond pulse durations using a single novel Q-Switched (QS) Nd:YAG laser.
Who can participate
Age range18 Years – 55 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 55 years of age (inclusive).
* Fitzpatrick Skin Type I - VI.
* Tattoos containing black/blue ink alone or in combination with other colors. No tribal, scarred, high-ink density, or highly colorful tattoos.
* Target tattoos older than 1 year.
* 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 by Investigator.
* 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.
* History of allergic reaction to pigments following tattooing.
* Presence of double tattoo in the treatment area or presence of tribal, scarred, high-ink dens…
What they're measuring
1
Level of Tattoo Clearing at 12 Weeks for Each Treatment Arm as Assessed by the Blinded Reviewers.