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A Study of a Novel Multi-Wavelength Laser for Tattoo Removal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02910505
Recruitment Status : Unknown
Verified September 2016 by Cutera Inc..
Recruitment status was:  Recruiting
First Posted : September 22, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

Brief Summary:
Single center study to evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM laser that offers multiple wavelengths for tattoo removal.

Condition or disease Intervention/treatment Phase
Tattoo Removal Device: enLighten Laser Not Applicable

Detailed Description:
A single-center prospective, open-label, uncontrolled pilot study to evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM laser that offers multiple wavelengths for tattoo removal.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : October 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Treatment
Treatment with investigational Cutera enlighten laser for tattoo removal
Device: enLighten Laser
Laser for tattoo removal




Primary Outcome Measures :
  1. Tattoo clearing as rated by Investigator [ 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. Tattoo clearing as rated by Subject [ Time Frame: 6 weeks post-final treatment ]
    Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the subject (Subject's Global Assessment of Improvement).

  2. Subject satisfaction Questionnaire [ Time Frame: 6 weeks post-final treatment ]
    Subject satisfaction levels at 6 weeks post-final treatment using Subject Satisfaction Assessment Scale.


Other Outcome Measures:
  1. Tattoo clearing as rated by Blinded Evaluator [ Time Frame: 6 weeks post-final treatment ]
    Degree of tattoo clearing at 6 weeks post-final treatment as assessed by independent blinded reviewers (Global Assessment of Improvement).

  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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): NCT02910505


Contacts
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Contact: Emily Hu 4156575543 ehu@cutera.com

Locations
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United States, Connecticut
Connecticut Skin Institute Recruiting
Stamford, Connecticut, United States, 06905
Contact: John Liongson    203-428-4440    admin@ctskindoc.com   
Sponsors and Collaborators
Cutera Inc.
Investigators
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Principal Investigator: Omar Ibrahimi, MD Connecticut Skin Institute
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Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT02910505    
Other Study ID Numbers: C-16-EN14
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No