Comparison Study of Picosecond and Nanosecond Pulse Durations Using a Q-switched Nd:YAG Laser for Tattoo Removal

Not Applicable

Completed

Conditions: Tattoo Removal

Interventions: Device: enLighten Laser

Registration Number: NCT02244554

Lead Sponsor: Cutera Inc.

Brief 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.

Detailed Description: This is a randomized, split-tattoo, open-label, single-center study of up to 25 subjects with tattoos containing black or dark blue ink, alone or in combination with other colors. It will compare the safety and efficacy of nanosecond and picosecond pulse durations with the Cutera Picosecond Q-Switched Nd:YAG laser for tattoo removal.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

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 density, or highly colorful single tattoos.
History of allergy to local anesthetics.
History of allergy to topical antibiotics.
History of malignant tumors in the target area.
Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
Pregnant and/or breastfeeding.
Having an infection, dermatitis or a rash in the treatment area.
Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
Suffering from coagulation disorders or taking prescription anticoagulation medications.
History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
History of vitiligo, eczema, or psoriasis.
History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
History of seizure disorders due to light.
Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion.
History of herpes simplex and/or herpes zoster (shingles).
History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
Systemic use of corticosteroid within 12 months of study participation.
Use of oral isotretinoin within 12 months of study participation and topical use of isotretinoin within 6 months on the treated area.
Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
Current smoker or history of smoking within 6 months of study participation.
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
enLighten Laser Nanosecond Pulse	enLighten Laser	Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment
enLighten Laser Picosecond Pulse	enLighten Laser	Picosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment

Primary Outcome Measures

Name	Time	Method
Level of Tattoo Clearing at 12 Weeks for Each Treatment Arm as Assessed by the Blinded Reviewers.	12 weeks	Physician's Global Assessment (min=0; Max=4) Higher scores indicate better outcomes

Secondary Outcome Measures