Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser

NCT ID: NCT02431104

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-02-22

Brief Summary

A single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink.

Detailed Description

This is a single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink. Subjects will receive up to 5 laser treatments, spaced 4 to 6 weeks apart, and will be followed at 3 months post-final treatment. Number of laser treatments required shall be based upon tattoo response to laser irradiation. The Investigator will terminate laser treatments upon 100% clearance of tattoo or after 5 treatment sessions, or in the event of an adverse effect which requires cessation of laser treatment.

Conditions

Laser Tattoo Removal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser Treatment

Treatment to unwanted tattoo using a 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser

Group Type: EXPERIMENTAL

532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser

Intervention Type: DEVICE

Cutera enlighten dual wavelength 532nm KTP/1064nm Nd:YAG laser

Interventions

532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser

Cutera enlighten dual wavelength 532nm KTP/1064nm Nd:YAG laser

Intervention Type: DEVICE

Other Intervention Names

Enlighten laser

Eligibility Criteria

Inclusion Criteria

• Fitzpatrick Skin Type I - VI
• Target tattoo contains only black ink, is more than 1 year old and must have been obtained from a professional tattoo parlor.
• Wiling to cover tattoos with a bandage or clothing; and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area starting 2 to 4 weeks before the treatment and/or every day for the duration of the study, including the follow-up period.

Exclusion Criteria

• Target tattoo is 'home made' OR was obtained from an amateur artist.
• Presence of double tattoo in the treatment area or presence of tribal, scarred, high-ink density, or highly colorful single tattoo.
• Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
• History of allergic reaction to pigments following tattooing.
• History of allergy to local anesthetics.
• History of malignant tumors in the target area.
• History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
• Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
• Current smoker or history of smoking within 6 months of study participation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cutera Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheetal Sapra, MD

Role: PRINCIPAL_INVESTIGATOR

ICLS Dermatology and Plastic Surgery

Locations

ICLS Dermatology and Plastic Surgery

Oakville, Ontario, Canada

Countries

Canada

Other Identifiers

C-15-EN02

Identifier Type: -

Identifier Source: org_study_id