Evaluation of the 755nm Alexandrite for Unwanted Tattoos

NCT ID: NCT01842815

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-12-31

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 a 755nm Alexandrite laser.

Conditions

Unwanted, Non Cosmetic, Tattoos

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

755nm Alexandrite Laser Single Pass (Right Side).

755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The right side will be treated once within the same visit.

Group Type: EXPERIMENTAL

755 nm alexandrite laser

Intervention Type: DEVICE

755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.

755nm Alexandrite Laser Double Pass (Left Side)

755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The left side of the tattoo will be treated twice within the same visit 20 minutes apart.

Group Type: EXPERIMENTAL

755 nm alexandrite laser

Intervention Type: DEVICE

755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.

Interventions

755 nm alexandrite laser

755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.

Intervention Type: DEVICE

Eligibility Criteria

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

Cynosure, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Krantz

Role: STUDY_DIRECTOR

Cynosure, Inc.

Locations

Laser & Skin Surgery Center of Northern California

Sacramento, California, United States

Countries

United States

Other Identifiers

CYN13-PICO-SK

Identifier Type: -

Identifier Source: org_study_id