Clinical Evaluation of 755nm Alexandrite Laser Versus Nanosecond 755nm Alexandrite

Compare the efficacy of the 755nm Alexandrite laser to the nanosecond 755nm Alexandrite laser for the removal of unwanted tattoos using photographic evaluation and histological findings.

Study Overview

• Status: Withdrawn
• Conditions: Tattoos
• Intervention / Treatment: Device: 755nm Alexandrite Laser

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • Boston VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
3. Is willing to consent to participate in the study.
4. Is willing to shield the tattoo completely from sun exposure
5. Signs informed consent form
6. 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. Subjects who are unwilling to consent to tattoos
2. Subjects mentally ill or incompetent
3. Subjects is unwilling to have photographs taken and used in publications or scientific presentations
4. Subjects who are prisoners
5. Subjects with recent sun exposure and suntan in the area to be treated
6. Allergic tattoos (hypersensitivity to tattoo ink)
7. History of vitiligo or keloidal scarring
8. Tattoos located on the neck or face including cosmetic tattoos
9. Subjects unwilling to tolerate partial removal of the tattoo in this study
10. Infection or skin disease in the area to be treated
11. Subjects who are immunosuppressed (e.g. HIV)
12. Subject is pregnant or nursing
13. Use of oral isotretinoin within past 12 months
14. History of squamous cell carcinoma or melanoma
15. Is allergic to Lidocaine, tetracaine or Xylocaine with epinephrine.
16. Has any other reason determined by the physician to be ineligible to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 755nm Alexandrite Laser	Device: 755nm Alexandrite Laser; 755nm Alexandrite Laser
Experimental: Nanosecond 755nm Alexandrite Laser	Device: 755nm Alexandrite Laser; 755nm Alexandrite Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Photographic Evaluation of Tattoo Clearance	up to 3 months post last treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject biopsy sampling	Histological evaluation of tissue samples pre-treatment and post-treatment	up to 3 months post last treatment

Other Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events as a measure of safety and tolerability	up to 3 months post last treatment

Collaborators and Investigators

• Sponsor: Cynosure, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: March 12, 2013
• First Posted (Estimate): March 14, 2013

Study Record Updates

• Last Update Posted (Estimate): February 5, 2014
• Last Update Submitted That Met QC Criteria: February 3, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: CYN12-PICO_MGH_TB