Laser Treatment of Tattoos With Pico Laser

Not Applicable

Completed

• Conditions: Unwanted Tattoos
• Interventions: Device: Picosecond Laser system

• Registration Number: NCT02146807
• Lead Sponsor: Syneron Medical

Brief Summary

The purpose of this study is to determine whether Pico laser is effective and safe in the treatment of unwanted tattoos.

Detailed Description

The Investigational device is a dual wavelength laser system developed for treatment of pigmented lesions and for tattoo removal. The base unit is a GentleMax Pro laser system modified to emit light at wavelengths of 532 and 1064 nm and deliver pulse energy up to 400mJ, and pulse duration of 700 ps.

A multicenter study.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-23
• Study First Posted: 2014-05-26
• Primary Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Has Fitzpatrick skin type I-IV
2. Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them
3. Is willing to consent to participate in the study
4. 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. Is hypersensitive to light exposure
2. Has an active sun tan
3. Has Fitzpatrick skin type V or VI
4. Has active localized or systemic infection
5. Is taking medication(s) for which sunlight is a contraindication
6. Has a history of squamous cell carcinoma or melanoma
7. Has a history of keloid scarring
8. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
9. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications
10. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period
11. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Picosecond Laser System	Picosecond Laser system	-

Primary Outcome Measures

Name	Time	Method
Global percentage of tattoo clearance	3 months post the final treatment	Global percentage of tattoo clearance evaluated by blinded observers using post treatment photographs compared to baseline photographs.

Secondary Outcome Measures

Name	Time	Method
Rate of tattoo clearance	3 months	The average number of treatments will be determined in order to obtain 50% and 75% tattoo clearance. Rate of clearance will be assessed globally independent of tattoo color and based on individual colors.

Trial Locations

Locations (3)

Main Line Center for Laser Surgery; 🇺🇸 Ardmore, Pennsylvania, United States

New York Laser and Skin Care; 🇺🇸 New York, New York, United States

Washington Institute of Dermatologic Laser Surgery; 🇺🇸 Washington, District of Columbia, United States