Picosure Alexandrite Laser and Revlite Nd:Yag Laser for the Treatment of Unwanted Tattoos

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Westford, Massachusetts, United States, 01886
      • Cynosure Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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 sensitizing 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 keloid scar formation.
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.14. The subject has red tattoo ink allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

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
EXPERIMENTAL: Revlite Laser System; Revlite Laser System for the Treatment of Unwanted Tattoos	Device: Revlite Laser System; Revlite Laser System for the Treatment of Unwanted Tattoos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tattoo Clearance	Clearance will be measured using a blinded photograph evaluation scale. This ranges from 0 to 3, where a score of 0 is 0-25%, 1 is 25-50% clearance rating, 2 is 50-75%, and 3 is >75%. Photographs will be taken of the subjects at baseline and post treatment. The results will be compared to determine clearance.	2 months post each patient's last treatment, approximately 15 months

Collaborators and Investigators

• Sponsor: Cynosure, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): March 1, 2017
• Study Completion (ACTUAL): March 1, 2017

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): February 9, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CYN13-PICOREVLITE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes