N/A
N=20
Evaluation of the 755nm Alexandrite Laser for the Treatment of Tattoos
Tattoos
Bottom Line
View on ClinicalTrials.gov: NCT01754207 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Tattoo Clearance Using Photographic Evaluation — 15; 6; 2 Tattoos
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 755nm Alexandrite Laser (Device); 755nm Alexandrite Laser with CAP Array (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cynosure, Inc.
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tattoo Clearance Using Photographic Evaluation |
15; 6; 2 | — |
Summary
The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using the 755nm Alexandrite laser.
Eligibility Criteria
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 to remove them.
- Is willing to consent to participate in the study.
- 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
- Is hypersensitive to light exposure.
- Has active localized or systemic infection.
- Is taking medication(s) for which sunlight is a contraindication.
- Has a history of squamous cell carcinoma or melanoma.
- Has a history of keloid scarring.
- Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
- Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- 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.
Data sourced from ClinicalTrials.gov (NCT01754207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.