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

Sponsor

Cutera Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02244554

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tattoo Removal	Device: enLighten Laser	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: enLighten Laser Picosecond Pulse Picosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment	Device: enLighten Laser Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment
Experimental: enLighten Laser Nanosecond Pulse Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment	Device: enLighten Laser Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment

Arm

Intervention/Treatment

Experimental: enLighten Laser Picosecond Pulse

Picosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment

Device: enLighten Laser

Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment

Experimental: enLighten Laser Nanosecond Pulse

Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment

Device: enLighten Laser

Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment

Outcome Measures

Primary Outcome Measures

Mean tattoo clearing score for treatment arm and active control arm as assessed by blinded reviewers, as measured by 5-point improvement scale. [Day 0, 4 weeks and 8 weeks]

Secondary Outcome Measures

Mean tattoo clearing score for treatment arm and active control arm as assessed by treated investigator, as measured by 5-point improvement scale. [Day 0, 4 weeks and 8 weeks]
Mean tattoo clearing score for treatment arm and active control arm as assessed by subject, as measured by 5-point improvement scale. [Day 0, 4 weeks and 8 weeks]
Mean pain score for treatment arm and active control arm as assessed by subject, as measured by 0 to 10 Numeric Pain Rating Scale. [at time of Laser treatment]
Subject satisfaction for treatment arm and active control arm, as determined by subject questionnaire. [Day 0, 4 weeks and 8 weeks]
Number of Participants with Adverse Effects for treatment arm and active control arm. [Day 0, 4 weeks and 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.