Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo Removal

Not Applicable

Completed

Conditions: Tattoo Removal

Interventions: Device: Picosecond Q-switched Laser Treatment
Device: Nanosecond Q-switched Laser Treatment

Registration Number: NCT01973166

Lead Sponsor: Cutera Inc.

Brief 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.

Detailed Description: This is a two center study to evaluate the Cutera RF system. Subjects will be treated on the abdomen and / or flanks areas and / or saddle bag (upper lateral thigh, lateral hip and lower buttocks).

The objective of this study is to evaluate the thermal and histological changes observed in the subcutaneous tissue following RF exposure.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 42

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 allergic reaction to pigments following tattooing
Presence of double tattoo in the treatment area
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, such as tetracycline
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
Picosecond Q-switched Laser Treatment	Picosecond Q-switched Laser Treatment	Picosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser
Nanosecond Q-switched Laser Treatment	Nanosecond Q-switched Laser Treatment	Nanosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser

Primary Outcome Measures

Name	Time	Method
Tattoo Clearing at 6 Weeks Post-final Laser Treatment for Each Treatment Arm as Assessed by Blinded Reviewers.	6-weeks post-final treatment	Physician's Global Assessment Scale: 0 (min) - 4 (max) Higher scores represent better tattoo clearing 4 = Very Significant Clearing (\> 75%) 3 = Significant Clearing (51 - 75%) 2 = Moderate Clearing (26 - 50%) 1 = Mild Clearing (5 - 25%) 0 = No Change (\< 5%)

Secondary Outcome Measures

Name	Time	Method
Comparison of Subject Discomfort (Pain) Between Treatment and Active Control Treatment Arms During Treatment	During treatment, approximately 10 minutes	Numeric Pain Rating Scale (Min=0; Max=10) Higher scores mean worse outcome