- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01973166
Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo Removal
Randomized, Split-tattoo Study Comparing Safety and Efficacy of Picosecond and Nanosecond Q-switched Nd:YAG Lasers for Tattoo Removal
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a two center study to evaluate the Cutera RF system. Subjects will be treated on the abdomen and / or flanks areas and / or saddle bag (upper lateral thigh, lateral hip and lower buttocks).
The objective of this study is to evaluate the thermal and histological changes observed in the subcutaneous tissue following RF exposure.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Brisbane, California, United States, 94005
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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, such as tetracycline
- History of herpes simplex and/or herpes zoster (shingles)
- 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 within 12 months of study participation
- Use of oral isotretinoin within 12 months of study participation and topical use of isotretinoin within 6 months on the treated area
- Anytime in life, having have 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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Picosecond Q-switched Laser Treatment
Picosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser
|
|
Active Comparator: Nanosecond Q-switched Laser Treatment
Nanosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tattoo Clearing at 6 Weeks Post-final Laser Treatment for Each Treatment Arm as Assessed by Blinded Reviewers.
Time Frame: 6-weeks post-final treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Subject Discomfort (Pain) Between Treatment and Active Control Treatment Arms During Treatment
Time Frame: During treatment, approximately 10 minutes
|
Numeric Pain Rating Scale (Min=0; Max=10) Higher scores mean worse outcome
|
During treatment, approximately 10 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Apfelberg, Study Principal Investigator
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- C-13-TPS04
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.
Clinical Trials on Tattoo Removal
-
Massachusetts General HospitalCompletedTattoo Removal | TattooUnited States
-
Cutera Inc.CompletedTattoo RemovalUnited States
-
Cutera Inc.Completed
-
Cutera Inc.WithdrawnLaser Tattoo RemovalCanada
-
Cutera Inc.Completed
-
Cutera Inc.Completed
-
Cutera Inc.CompletedTattoo RemovalUnited States
-
Assaf-Harofeh Medical CenterUnknownRemoval of Colors Tattoo (Multiple Colors)Israel
Clinical Trials on Picosecond Q-switched Laser Treatment
-
Mahidol UniversityUnknownBenign Pigmented LesionsThailand
-
Bispebjerg HospitalCompleted
-
Shahid Beheshti University of Medical SciencesCompletedSolar LentiginesIran, Islamic Republic of
-
Cairo UniversityRecruitingHyperpigmentation | Melasma | Lasers | PRPEgypt
-
Kasr El Aini HospitalCompleted
-
University of ZurichCompletedSolar LentiginesSwitzerland
-
National University Hospital, SingaporeCompletedChronic Angle Closure Glaucoma | Primary Angle Closure | Primary Angle Closure Suspect | Fellow Eyes of Acute Angle Closure GlaucomaSingapore
-
Cynosure, Inc.Terminated
-
ConBio, a Cynosure CompanyCompleted