Multi-Wavelength Laser Tattoo Removal Pivotal Study
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 1/24/2018 |
Start Date: | October 2016 |
End Date: | June 2018 |
Contact: | Emily Hu |
Email: | ehu@cutera.com |
Phone: | 4156575543 |
A Prospective, Multi-Center Pivotal Clinical Evaluation of a Novel Multi-Wavelength Laser for Tattoo Removal
Mult-center study to evaluate the safety and efficacy of an investigational version of the
Cutera enlighten laser that offers multiple wavelengths for tattoo removal
Cutera enlighten laser that offers multiple wavelengths for tattoo removal
A multi-center prospective, open-label, uncontrolled pivotal study to evaluate the safety and
efficacy of an investigational version of the Cutera enlighten laser that offers multiple
wavelengths for tattoo removal.
efficacy of an investigational version of the Cutera enlighten laser that offers multiple
wavelengths for tattoo removal.
Inclusion Criteria:
- Female or Male, 18 to 65 years of age (inclusive).
- Fitzpatrick Skin Type I - VI.
- Target tattoo contains single or multi-color ink, and must include blue and/or green
ink.
- Target tattoos must be older than 1 year.
- Target treatment area not to exceed 12 square inches.
- Subject 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 have digital photographs taken of the treatment area and agree to use of
photographs for presentation, educational or marketing purposes.
- Agree to not undergo any other procedure(s) for tattoo removal during the study (as
applicable).
- 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, and no plans to become pregnant for the duration of the study.
Exclusion Criteria:
- Participation in a clinical trial of a drug or another device in the target area
during the study.
- Target tattoo contains only black ink.
- History of allergic reaction to pigments following tattooing.
- 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 per investigator's discretion.
- 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
Investigator's discretion.
- History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes
zoster (shingles) in the treatment area, unless treatment is conducted following a
prophylactic regimen.
- 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 or isotretinoin, as applicable, within 6 months of
study participation.
- Anytime in life, having 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.
We found this trial at
2
sites
3240 Bayshore Boulevard
Brisbane, California 94005
Brisbane, California 94005
Principal Investigator: Stephen Ronan, MD
Phone: 415-657-5749
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Chestnut Hill, Massachusetts 02467
Principal Investigator: Jeffrey Dover, MD
Phone: 617-848-1638
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