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

Laser Tattoo Removal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02431104
• Other study ID #: C-15-EN02
• Status: Withdrawn
• Phase: N/A
• Start date: April 2015
• Est. completion date: February 22, 2016

Study information

• Verified date: January 2023
• Source: Cutera Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 22, 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laser Tattoo Removal

Intervention

Device:
• 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser
Cutera enlighten dual wavelength 532nm KTP/1064nm Nd:YAG laser

Locations

Country	Name	City	State
Canada	ICLS Dermatology and Plastic Surgery	Oakville	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Cutera Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician's Global Assessment of improvement post-final treatment	Assessment of tattoo clearance by independent blinded reviewers	3 months
Secondary	Subject's Global Assessment of improvement post-final treatment	Assessment of tattoo clearance by subject	3 months
Secondary	Subject Satisfaction post-final treatment	Assessment of subject satisfaction with treatment results.	3 months
Secondary	Incidence and severity of adverse device effects	Assessment of ADEs immediately following each laser treatment and at the final follow-up visit.	Day 0, 4 wks, 8wks, 12 wks, 16 wks, 28 wks