- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02756806
A Clinical Evaluation for Tattoo Removal
January 26, 2023 updated by: Cutera Inc.
A Clinical Evaluation of a Novel Multi-Wavelength Laser for Tattoo Removal
Evaluate safety and efficacy with the enlighten laser for tattoo removal.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The purpose of this investigation is to evaluate the safety and efficacy of an investigational version of the Cutera enlighten laser for tattoo removal.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Brisbane, California, United States, 94005
- Cutera Research Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- History of seizure disorders due to light.
- Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
- History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen
- History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Systemic use of corticosteroid or isotretinoin within 6 months of study participation.
- Anytime in life, having used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
- 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.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Picosecond Q-switched Laser
Treatment with investigational wavelengths of the Cutera enlighten laser for tattoo removal.
|
Each subject will receive laser treatments with Enlighten laser
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of Tattoo Clearing
Time Frame: 12-weeks post-final treatment
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tattoo clearing
Time Frame: 6-weeks post-final treatment
|
Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement).
|
6-weeks post-final treatment
|
Subject satisfaction
Time Frame: 6-weeks post-final treatment
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At 6 weeks, post-final treatment subjects will be asked to rate their level of satisfaction with the laser treatment outcome, using the Subject Satisfaction Assessment Scale.
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6-weeks post-final treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lourdes Moldre, NP, Cutera Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Actual)
September 28, 2016
Study Completion (Actual)
September 28, 2016
Study Registration Dates
First Submitted
April 28, 2016
First Submitted That Met QC Criteria
April 28, 2016
First Posted (Estimate)
April 29, 2016
Study Record Updates
Last Update Posted (Estimate)
February 21, 2023
Last Update Submitted That Met QC Criteria
January 26, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- C-16-EN11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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