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

Not Applicable

Withdrawn

• Conditions: Tattoos
• Interventions: Device: 755nm Alexandrite Laser

• Registration Number: NCT01811017
• Lead Sponsor: Cynosure, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-14
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-03
• Last Update Posted: 2014-02-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
755nm Alexandrite Laser	755nm Alexandrite Laser	755nm Alexandrite Laser
Nanosecond 755nm Alexandrite Laser	755nm Alexandrite Laser	Nanosecond 755nm Alexandrite Laser

Primary Outcome Measures

Name	Time	Method
Photographic Evaluation of Tattoo Clearance	up to 3 months post last treatment

Secondary Outcome Measures

Name	Time	Method
Subject biopsy sampling	up to 3 months post last treatment	Histological evaluation of tissue samples pre-treatment and post-treatment

Trial Locations

Locations (1)

Boston Va Medical Center; 🇺🇸 Boston, Massachusetts, United States