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

Not Applicable

Completed

• Conditions: Tattoos
• Interventions: Device: 755nm Alexandrite Laser; Device: 755nm Alexandrite Laser with CAP Array

• Registration Number: NCT01754207
• Lead Sponsor: Cynosure, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-21
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Results First Submitted: 2020-10-28
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-20
• Last Update Submitted: 2020-11-20
• Results First Posted: 2020-12-16
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
755nm Alexandrite Laser	755nm Alexandrite Laser with CAP Array	755nm Alexandrite Laser
755nm Alexandrite Laser	755nm Alexandrite Laser	755nm Alexandrite Laser

Primary Outcome Measures

Name	Time	Method
Tattoo Clearance Using Photographic Evaluation	up to 3 months post last treatment	2D photography comparing pre and post treatment photos, where the percentage of tattoo clearance between the photos was determined by the evaluator.

Trial Locations

Locations (1)

Skin Care Physicians; 🇺🇸 Chestnut Hill, Massachusetts, United States