Overview

This trial is active, not recruiting.

Condition unwanted tattoos
Treatment picosure laser system
Sponsor Cynosure, Inc.
Start date September 2013
End date January 2017
Trial size 40 participants
Trial identifier NCT02103153, CYN13-PICO532-RG5

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

Primary Outcomes

Measure
Compare level of clearance using a photographic scale
time frame: 2 months post treatment

Secondary Outcomes

Measure
Assess Investigator and subject satisfaction by questionnaire
time frame: 2 months post treatment

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: 1. Is a healthy non-smoking (must have quit 6 months prior) male or female between 18 and 65 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. Has unwanted non-cosmetic tattoo containing red ink, that has not previously been treated, and wishes to undergo laser treatment Exclusion Criteria: 1. The subject 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. The subject is hypersensitive to light exposure OR takes photo sensitized medication. 3. The subject has active or localized systemic infections. 4. The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}). 5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. 6. The subject 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. The subject has used Accutane within 6 months prior to enrollment. 8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. 9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate). 10. The subject has a history of keloids. 11. The subject has evidence of compromised wound healing. 12. The subject has a history of basal cell carcinoma, squamous cell carcinoma or melanoma. 13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.

Additional Information

Official title Clinical Evaluation of the Picosure 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..