Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo Removal
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 5/5/2014 |
Start Date: | September 2013 |
Contact: | Shelby Baker |
Email: | sbaker@cutera.com |
Phone: | 415-657-5749 |
Randomized, Split-tattoo Study Comparing Safety and Efficacy of Picosecond and Nanosecond Q-switched Nd:YAG Lasers for Tattoo Removal
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.
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
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