Randomized, Controlled, Comparison Study of Picosecond and Nanosecond Q-switched Nd:YAG Lasers for Resistant Tattoo Removal

Trial ID:
IRB-13-6242
E. Victor Ross
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.

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

Contact Info:

  • Shelby Baker
  • sbaker@cutera.com
  • 415-657-5749