Clinical Evaluation of 755nm Alexandrite Laser Versus Nanosecond 755nm Alexandrite

Cynosure

Status

Withdrawn

Conditions

Tattoos

Treatments

Device: 755nm Alexandrite Laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT01811017

CYN12-PICO_MGH_TB

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Is a healthy male or female between 18 and 85 years old?
Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments
Is willing to consent to participate in the study.
Is willing to shield the tattoo completely from sun exposure
Signs informed consent form
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

Subjects who are unwilling to consent to tattoos
Subjects mentally ill or incompetent
Subjects is unwilling to have photographs taken and used in publications or scientific presentations
Subjects who are prisoners
Subjects with recent sun exposure and suntan in the area to be treated
Allergic tattoos (hypersensitivity to tattoo ink)
History of vitiligo or keloidal scarring
Tattoos located on the neck or face including cosmetic tattoos
Subjects unwilling to tolerate partial removal of the tattoo in this study
Infection or skin disease in the area to be treated
Subjects who are immunosuppressed (e.g. HIV)
Subject is pregnant or nursing
Use of oral isotretinoin within past 12 months
History of squamous cell carcinoma or melanoma
Is allergic to Lidocaine, tetracaine or Xylocaine with epinephrine.
Has any other reason determined by the physician to be ineligible to participate in the study