Clinical Evaluation of the Picosure Laser for the Treatment of Unwanted Tattoos

NCT ID: NCT02103153

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-01-31

Brief Summary

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

Conditions

Unwanted Tattoos

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Picosure Laser System

Group Type: EXPERIMENTAL

Picosure Laser System

Intervention Type: DEVICE

Interventions

Picosure Laser System

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

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.

• 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

Laser & Skin Surgery Center of New York

New York, New York, United States

Countries

United States

Other Identifiers

CYN13-PICO532-RG5

Identifier Type: -

Identifier Source: org_study_id