Tattoos
Conditions
Brief summary
Compare the efficacy of the 755nm Alexandrite laser to the nanosecond 755nm Alexandrite laser for the removal of unwanted tattoos using photographic evaluation and histological findings.
Interventions
DEVICE755nm Alexandrite Laser
755nm Alexandrite Laser
Sponsors
Cynosure, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Is a healthy male or female between 18 and 85 years old? 2. Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments 3. Is willing to consent to participate in the study. 4. Is willing to shield the tattoo completely from sun exposure 5. Signs informed consent form 6. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
Exclusion criteria
1. Subjects who are unwilling to consent to tattoos 2. Subjects mentally ill or incompetent 3. Subjects is unwilling to have photographs taken and used in publications or scientific presentations 4. Subjects who are prisoners 5. Subjects with recent sun exposure and suntan in the area to be treated 6. Allergic tattoos (hypersensitivity to tattoo ink) 7. History of vitiligo or keloidal scarring 8. Tattoos located on the neck or face including cosmetic tattoos 9. Subjects unwilling to tolerate partial removal of the tattoo in this study 10. Infection or skin disease in the area to be treated 11. Subjects who are immunosuppressed (e.g. HIV) 12. Subject is pregnant or nursing 13. Use of oral isotretinoin within past 12 months 14. History of squamous cell carcinoma or melanoma 15. Is allergic to Lidocaine, tetracaine or Xylocaine with epinephrine. 16. Has any other reason determined by the physician to be ineligible to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Photographic Evaluation of Tattoo Clearance | up to 3 months post last treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject biopsy sampling | up to 3 months post last treatment | Histological evaluation of tissue samples pre-treatment and post-treatment |
Other
| Measure | Time frame |
|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | up to 3 months post last treatment |
Countries
United States
Outcome results
None listed