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

NCT ID: NCT02110121

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-03-31

Brief Summary

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

Conditions

Unwanted Tattoos

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Picosure Laser System

Picosure Laser System for the Treatment of Unwanted Tattoos

Group Type: EXPERIMENTAL

Picosure Laser System

Intervention Type: DEVICE

Picosure Laser System for the Treatment of Unwanted Tattoos

Revlite Laser System

Revlite Laser System for the Treatment of Unwanted Tattoos

Group Type: EXPERIMENTAL

Revlite Laser System

Intervention Type: DEVICE

Revlite Laser System for the Treatment of Unwanted Tattoos

Interventions

Picosure Laser System

Picosure Laser System for the Treatment of Unwanted Tattoos

Intervention Type: DEVICE

Revlite Laser System

Revlite Laser System for the Treatment of Unwanted Tattoos

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cynosure, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Krantz

Role: STUDY_DIRECTOR

Cynosure, Inc.

Locations

Cynosure Inc.

Westford, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

CYN13-PICOREVLITE

Identifier Type: -

Identifier Source: org_study_id