A Clinical Evaluation for Tattoo Removal

NCT02756806 | Terminated Results

• 1 other identifier: C-16-EN11
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate safety and efficacy with the enlighten laser for tattoo removal.

Conditions

Tattoo Removal

Keywords

Tattoo removal, Picosecond Laser, Q-switched Laser

Outcome Measures

Primary Outcomes (1)

• Degree of Tattoo Clearing

  Degree of tattoo clearing at 12 weeks post-final treatment as assessed by independent blinded reviewers (Physician's Global Assessment of Improvement). Min=0; Max=4 Higher score indicate 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%)

  12-weeks post-final treatment

Study Arms (1)

Picosecond Q-switched Laser

EXPERIMENTAL

Treatment with investigational wavelengths of the Cutera enlighten laser for tattoo removal.

Device: Picosecond Q-switched laser

Interventions

Picosecond Q-switched laser DEVICE

Each subject will receive laser treatments with Enlighten laser

Also known as: Enlighten

Picosecond Q-switched Laser

Eligibility Criteria

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

You may qualify if:

• Female or Male, 18 to 65 years of age (inclusive).
• Fitzpatrick Skin Type I - VI (Appendix 3).
• Target tattoo contains single or multi-color ink, which includes blue and/or green.
• Target tattoos must be older than 1 year.
• Target tattoo not to exceed 12 square inches.
• Subject 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 have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
• Agree to not undergo any other procedure(s) for tattoo removal during the study (as applicable).
• 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, and no plans to become pregnant for the duration of the study.

You may not qualify if:

• Participation in a clinical trial of a drug or another device in the target area within 6 months prior to enrollment or during the study.
• Target tattoo contains only black ink.
• Target tattoo is a double tattoo where a first tattoo was covered with a second tattoo.
• History of allergic reaction to pigments following tattooing.
• 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)

Cutera Research Center

Brisbane, California, 94005, United States

Location

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-657-5518

Study Officials

• Lourdes Moldre, NP

  Cutera Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: April 29, 2016
• Study Start: April 1, 2016
• Primary Completion: September 28, 2016
• Study Completion: September 28, 2016
• Last Updated: February 21, 2023
• Results First Posted: February 21, 2023

Record last verified: 2023-01

Locations

US (1)