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

Tattoos Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754207
• Other study ID #: CYN11-PICO-D-A-TAT
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: January 2014

Study information

• Verified date: November 2020
• Source: Cynosure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tattoos

Intervention

Device:
• 755nm Alexandrite Laser
755nm Alexandrite Laser
• 755nm Alexandrite Laser with CAP Array
755nm Alexandrite Laser with CAP Array

Locations

Country	Name	City	State
United States	Skin Care Physicians	Chestnut Hill	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cynosure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tattoo Clearance Using Photographic Evaluation	2D photography comparing pre and post treatment photos, where the percentage of tattoo clearance between the photos was determined by the evaluator.	up to 3 months post last treatment