Overview

This trial is active, not recruiting.

Condition unwanted tattoos
Treatment picosure laser system
Sponsor Cynosure, Inc.
Start date January 2014
End date November 2016
Trial size 20 participants
Trial identifier NCT02110095, CYN14-PICO-MULTI-JD

Summary

The purpose of this study is to evaluate the Picosure Laser System for the treatment of unwanted tattoos.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Picosure Laser System for the treatment of unwanted tattoos
picosure laser system
Picosure Laser System for the Treatment of Unwanted Tattoos

Primary Outcomes

Measure
Tattoo Clearance
time frame: 2 months post last treatment

Secondary Outcomes

Measure
Satisfaction Questionnaire
time frame: 2 months post last treatment

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: 1. Is a healthy male or female between 18 and 85 years old. 2. Is willing to consent to participate in the study. 3. 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. 4. The tattoo must include red pigment. Exclusion Criteria: 1. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. 2. Is hypersensitive to light exposure OR takes photo sensitized medication. 3. Has active or localized systemic infections. 4. 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}). 5. Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. 6. 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. 7. Has used Accutane within 6 months prior to enrollment. 8. Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. 9. Has had prior treatment with parenteral gold therapy (gold sodium thiomalate). 10. Has a history of keloids. 11. Has evidence of compromised wound healing. 12. Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma. 13. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder. 14. Is allergic to topical lidocaine or topical steroids.

Additional Information

Official title Picosure Alexandrite Laser for the Treatment of Unwanted Tattoos
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Cynosure, Inc..