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Evaluation of the 755nm Alexandrite Laser for the Treatment of Tattoos

NCT ID: NCT01754207

Last Updated: 2020-12-16

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-01-31

Brief Summary

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The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using the 755nm Alexandrite laser.

Detailed Description

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Conditions

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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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755nm Alexandrite Laser

755nm Alexandrite Laser

Group Type EXPERIMENTAL

755nm Alexandrite Laser

Intervention Type DEVICE

755nm Alexandrite Laser

755nm Alexandrite Laser with CAP Array

Intervention Type DEVICE

755nm Alexandrite Laser with CAP Array

Interventions

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755nm Alexandrite Laser

755nm Alexandrite Laser

Intervention Type DEVICE

755nm Alexandrite Laser with CAP Array

755nm Alexandrite Laser with CAP Array

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. 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 active localized or systemic infection.
3. Is taking medication(s) for which sunlight is a contraindication.
4. Has a history of squamous cell carcinoma or melanoma.
5. Has a history of keloid scarring.
6. 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.
7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
10. Has any other reason determined by the physician to be ineligible to participate in the study.
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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CYN11-PICO-D-A-TAT

Identifier Type: -

Identifier Source: org_study_id