Comparison Study of Picosecond and Nanosecond Pulse Durations Using a Q-switched Nd:YAG Laser for Tattoo Removal

NCT02244554 | Completed Results

• 1 other identifier: C-14-TPS05
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of laser tattoo removal with picosecond pulse durations as compared to treatment with nanosecond pulse durations using a single novel Q-Switched (QS) Nd:YAG laser.

Conditions

Tattoo Removal

Keywords

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; resistant tattoo

Outcome Measures

Primary Outcomes (1)

• Level of Tattoo Clearing at 12 Weeks for Each Treatment Arm as Assessed by the Blinded Reviewers.

  Physician's Global Assessment (min=0; Max=4) Higher scores indicate better outcomes

  12 weeks

Study Arms (2)

enLighten Laser Picosecond Pulse

EXPERIMENTAL

Picosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment

Device: enLighten Laser

enLighten Laser Nanosecond Pulse

EXPERIMENTAL

Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment

Device: enLighten Laser

Interventions

enLighten Laser DEVICE

Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment

enLighten Laser Nanosecond Pulse; enLighten Laser Picosecond Pulse

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females or Males, 18 to 55 years of age (inclusive).
• Fitzpatrick Skin Type I - VI.
• Tattoos containing black/blue ink alone or in combination with other colors. No tribal, scarred, high-ink density, or highly colorful tattoos.
• Target tattoos older than 1 year.
• 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 by Investigator.
• 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.

You may not qualify if:

• Participation in a study of another device or drug within 6 months prior to enrollment or during the study.
• History of allergic reaction to pigments following tattooing.
• Presence of double tattoo in the treatment area or presence of tribal, scarred, high-ink density, or highly colorful single tattoos.
• 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.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (1)

Scripps Clinic Carmel Valley

San Diego, California, 92130, United States

Location

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-657-5518

Study Officials

• E. Victor Ross, MD

  Scripps Clinic Carmel Valley

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: September 19, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 21, 2023
• Results First Posted: February 21, 2023

Record last verified: 2023-01

Locations

US (1)