Picosure Alexandrite Laser for the Treatment of Unwanted Tattoos

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

Study Overview

• Status: Completed
• Conditions: Unwanted Tattoos
• Intervention / Treatment: Device: Picosure Laser System

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Skin Care Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Picosure Laser System; Picosure Laser System for the treatment of unwanted tattoos	Device: Picosure Laser System; Picosure Laser System for the Treatment of Unwanted Tattoos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Tattoo Clearance	Tattoo clearance will be measured using baseline and 2 month post treatment photos using a photographic scale. The scale ranges from 0 to 10, where 10 is 100% improvement from the baseline photo.	2 months post last treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Satisfaction Questionnaire	This measures the physician satisfaction from 1 to 5, where 5 is the most satisfied.	2 months post last treatment

Collaborators and Investigators

• Sponsor: Cynosure, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CYN14-PICO-MULTI-JD