Laser Treatment of Tattoos With Pico Laser

NCT ID: NCT02146807

Last Updated: 2015-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Unwanted Tattoos

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Picosecond Laser System

Group Type EXPERIMENTAL

Picosecond Laser system

Intervention Type DEVICE

Picosecond Laser System for the Treatment of Unwanted Tattoos

Interventions

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Picosecond Laser system

Picosecond Laser System for the Treatment of Unwanted Tattoos

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Syneron Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shlomit Mann

Role: STUDY_DIRECTOR

Syneron Medical Ltd.

Locations

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Washington Institute of Dermatologic Laser Surgery

Washington D.C., District of Columbia, United States

Site Status

New York Laser and Skin Care

New York, New York, United States

Site Status

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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IH132802

Identifier Type: -

Identifier Source: org_study_id

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