N/A
N=15
Picosure Alexandrite Laser for the Treatment of Unwanted Tattoos
Unwanted Tattoos
Bottom Line
View on ClinicalTrials.gov: NCT02110095 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Number of Patients With Tattoo Clearance — 3; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Picosure Laser System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cynosure, Inc.
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Tattoo Clearance |
3; 5 | — |
| SECONDARY Physician Satisfaction Questionnaire |
4; 4 | — |
Summary
The purpose of this study is to evaluate the Picosure Laser System for the treatment of unwanted tattoos.
Eligibility Criteria
Inclusion Criteria
- Is a healthy male or female between 18 and 85 years old.
- 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.
- The tattoo must include red pigment.
Exclusion Criteria
- 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 hypersensitive to light exposure OR takes photo sensitized medication.
- Has active or localized systemic infections.
- Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
- Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
- Has used Accutane within 6 months prior to enrollment.
- Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- Has a history of keloids.
- Has evidence of compromised wound healing.
- Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
- Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
- Is allergic to topical lidocaine or topical steroids.
Data sourced from ClinicalTrials.gov (NCT02110095). 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.