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Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo Removal

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ClinicalTrials.gov Identifier: NCT01973166
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

Brief Summary:
The purpose of this study is to compare the investigational medical grade laser device to a marketed medical grade laser device for effectiveness in lightening or clearing unwanted tattoos. This study will also compare any side effects from treatment with the devices.

Condition or disease Intervention/treatment Phase
Tattoo Removal Device: Picosecond Q-switched Laser Treatment Device: Nanosecond Q-switched Laser Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Split-tattoo Study Comparing Safety and Efficacy of Picosecond and Nanosecond Q-switched Nd:YAG Lasers for Tattoo Removal
Study Start Date : September 2013
Actual Primary Completion Date : July 2014

Arm Intervention/treatment
Experimental: Picosecond Q-switched Laser Treatment
Picosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser
Device: Picosecond Q-switched Laser Treatment
Active Comparator: Nanosecond Q-switched Laser Treatment
Nanosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser
Device: Nanosecond Q-switched Laser Treatment



Primary Outcome Measures :
  1. Tattoo clearing at 12 weeks post-final laser treatment for each treatment arm as assessed by blinded reviewers. [ Time Frame: 12-weeks post-final laser treatment ]

Secondary Outcome Measures :
  1. 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 ]
  2. Tattoo clearing at 12 weeks post-final laser treatment for each treatment arm as assessed by the treating investigator. [ Time Frame: 12-weeks post-final treatment ]
  3. Tattoo clearing at 12 weeks post-final treatment for each treatment arm as assessed by the subject [ Time Frame: 12-weeks post-final treatment ]
  4. Subject discomfort during laser treatment for each treatment arm. [ Time Frame: at time of Laser treatment ]
  5. Subject satisfaction for each treatment arm at 12 weeks post-final laser treatment. [ Time Frame: 12-weeks post-final laser treatment ]
  6. Incidence and severity of adverse device effects for each treatment arm during the study period. [ Time Frame: 12-weeks post-final laser treatment ]


Information from the National Library of Medicine

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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:

  • 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

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): NCT01973166


Locations
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United States, California
Brisbane, California, United States
Sponsors and Collaborators
Cutera Inc.

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Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT01973166     History of Changes
Other Study ID Numbers: C-13-TPS04
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: July 2014

Keywords provided by Cutera Inc.:
Tattoo Removal
Q-switched laser
Nd:YAG laser
Nanosecond laser
Picosecond laser
Laser therapy
Tattoo
pulsed-laser
laser treatment
remove tattoo
tattoo clearing
tattoo lightening
tattoo lighten