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 resistant tattoos. This study will also compare any side effects from treatment with the devices.

Inclusion Criteria:

  • Females or Males, 18 to 55 years of age (inclusive).
  • Fitzpatrick Skin Type I - IV.
  • 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.
  • Resistant Tattoos (at least 5 previous treatments with a nanosecond device (532nm or 1064nm) with incomplete clearing).
  • 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.
  • 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, 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.