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Split-tattoo Study Comparing the Safety and Efficacy of 670nm Picosecond Laser Versus 755 nm for Tattoo Removal

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ClinicalTrials.gov Identifier: NCT02912507
Recruitment Status : Active, not recruiting
First Posted : September 23, 2016
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

Brief Summary:
Study to evaluate safety and efficacy of treatment with the investigational Cutera enlighten laser for tattoo removal as compared to treatment with the Cynosure PicoSure laser

Condition or disease Intervention/treatment Phase
Tattoo Removal Device: Cutera enlighten laser Device: CynoSure PicoSure 755nm laser Not Applicable

Detailed Description:
This is an open-label, split-tattoo, single-center prospective, comparison study in up to 20 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo containing single or multi-color ink. Subjects will receive up to 10 laser treatments, spaced 1 to 10 weeks apart, and will be followed at 6 weeks (±2 weeks). At the Investigator's discretion, an optional follow-up visit may be conducted at 12 weeks (±2 weeks) post-final treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Split-tattoo Study Comparing the Safety and Efficacy of the 670nm Picosecond Laser Versus the 755 nm Picosecond Laser for Tattoo Removal
Actual Study Start Date : September 9, 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Investigational Enlighten Device
Tattoo removal treatments with the investigational Cutera enlighten laser
Device: Cutera enlighten laser
high-powered, Q-switched 670nm Picosecond laser system indicated for tattoo removal
Other Name: 670nm Picosecond Laser

Active Comparator: Cynosure PicoSure 755 nm laser
Tattoo removal treatments with the Cynosure PicoSure 755 nm laser
Device: CynoSure PicoSure 755nm laser
high-powered, Q-switched Alexandrite system that delivers laser energy in the 755 nm wavelength and has received FDA clearance (K133364) for tattoo and benign pigmented lesion removal.




Primary Outcome Measures :
  1. Degree of tattoo clearing as assessed by the Investigator (Physician's Global Assessment of Improvement) [ 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).


Secondary Outcome Measures :
  1. Subject satisfaction using the Subject Satisfaction Assessment Scale [ Time Frame: 6 weeks post-final treatment ]
    Subject satisfaction levels at 6 weeks post-final treatment using the Subject Satisfaction Assessment Scale.


Other Outcome Measures:
  1. Degree of tattoo clearing as assessed by Blinded Reviewer using the Global Assessment of Improvement Scale [ Time Frame: 6 weeks post-final treatment ]
    Degree of tattoo clearing at 6 weeks post-final treatment as assessed by independent blinded reviewers using the Global Assessment of Improvement Scale

  2. Adverse Device Effects [ Time Frame: through study completion, an average of 1 year ]
    Number and severity of adverse device effects during the study period, displayed as frequency counts.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female or Male, 18 to 65 years of age (inclusive).
  • Fitzpatrick Skin Type I - VI.
  • Target tattoo contains single or multi-color ink.
  • 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 during the study.
  • Target tattoo contains only black ink.
  • 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912507


Locations
United States, Florida
Laser Skin Solutions Jacksonville
Jacksonville Beach, Florida, United States, 32250
Sponsors and Collaborators
Cutera Inc.
Investigators
Principal Investigator: Jill Lezaic, DO Laser Skin Solutions Jacksonville

Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT02912507     History of Changes
Other Study ID Numbers: C-16-EN15
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No