Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo Removal

NCT01973166 | Completed Results

• 1 other identifier: C-13-TPS04
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the investigational medical grade laser device to a marketed medical grade laser device for effectiveness in lightening or clearing unwanted tattoos. This study will also compare any side effects from treatment with the devices.

Conditions

Tattoo Removal

Keywords

Tattoo Removal; Q-switched laser; Nd:YAG laser; Nanosecond laser; Picosecond laser; Laser therapy; Tattoo; pulsed-laser; laser treatment; remove tattoo; tattoo clearing; tattoo lightening; tattoo lighten

Outcome Measures

Primary Outcomes (1)

• Tattoo Clearing at 6 Weeks Post-final Laser Treatment for Each Treatment Arm as Assessed by Blinded Reviewers.

  Physician's Global Assessment Scale: 0 (min) - 4 (max) Higher scores represent better tattoo clearing 4 = Very Significant Clearing (\> 75%) 3 = Significant Clearing (51 - 75%) 2 = Moderate Clearing (26 - 50%) 1 = Mild Clearing (5 - 25%) 0 = No Change (\< 5%)

  6-weeks post-final treatment

Secondary Outcomes (1)

• Comparison of Subject Discomfort (Pain) Between Treatment and Active Control Treatment Arms During Treatment

  During treatment, approximately 10 minutes

Study Arms (2)

Picosecond Q-switched Laser Treatment

EXPERIMENTAL

Picosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser

Device: Picosecond Q-switched Laser Treatment

Nanosecond Q-switched Laser Treatment

ACTIVE COMPARATOR

Nanosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser

Device: Nanosecond Q-switched Laser Treatment

Interventions

Picosecond Q-switched Laser Treatment DEVICE

Picosecond Q-switched Laser Treatment

Nanosecond Q-switched Laser Treatment DEVICE

Nanosecond Q-switched Laser Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females or Males, 18 to 65 years of age (inclusive)
• Fitzpatrick Skin Type I - IV (Appendix 3)
• Tattoos containing black/blue ink alone or in combination with other colors
• Target tattoos older than 1 year
• Presence of tattoos equal or greater than 2 square inches, not to exceed 12 square inches
• Must be able to read, understand and sign the Informed Consent Form
• Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions
• 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
• Willing to use hydroquinone approximately 4 weeks pre-treatment and post- treatment if required
• Willingness to have digital photographs taken of the treated area
• Agree not to undergo any other procedure(s) for the tattoo removal during the study
• Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study

You may not qualify if:

• Participation in a study of another device or drug within 6 months prior to enrollment or during the study
• Prior treatment for tattoo removal in the target area, e.g., with q-switched laser, IPL, dermabrasion, electrocautery, cryotherapy
• History of allergic reaction to pigments following tattooing
• Presence of double tattoo in the treatment area
• History of allergy to local anesthetics
• History of allergy to topical antibiotics
• History of malignant tumors in the target area
• Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles
• Pregnant and/or breastfeeding
• Having an infection, dermatitis or a rash in the treatment area
• Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension
• Suffering from coagulation disorders or taking prescription anticoagulation medications
• History of keloid scarring, hypertrophic scarring or of abnormal wound healing
• History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications
• History of vitiligo, eczema, or psoriasis

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (1)

Unknown Facility

Brisbane, California, 94005, United States

Location

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-657-5518

Study Officials

• David Apfelberg

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: October 31, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 21, 2023
• Results First Posted: February 21, 2023

Record last verified: 2023-01

Locations

US (1)