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Picosure Alexandrite Laser for the Treatment of Unwanted Tattoos

NCT ID: NCT02110095

Last Updated: 2020-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-11-30

Brief Summary

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

Detailed Description

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Conditions

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Unwanted Tattoos

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Interventions

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Picosure Laser System

Picosure Laser System for the Treatment of Unwanted Tattoos

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Is a healthy male or female between 18 and 85 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. The tattoo must include red pigment.

Exclusion Criteria

1. 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. Is hypersensitive to light exposure OR takes photo sensitized medication.
3. Has active or localized systemic infections.
4. Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
5. Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. 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. Has used Accutane within 6 months prior to enrollment.
8. Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. Has a history of keloids.
11. Has evidence of compromised wound healing.
12. Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
13. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
14. Is allergic to topical lidocaine or topical steroids.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cynosure, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia Krantz

Role: STUDY_DIRECTOR

Cynosure, Inc.

Locations

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Skin Care Physicians

Chestnut Hill, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CYN14-PICO-MULTI-JD

Identifier Type: -

Identifier Source: org_study_id