NCT03290547

Brief Summary

To evaluate the safety and efficacy of an investigational version of the Cutera enLighten laser that offers muliple wavelengths for tattoo removal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2017

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

September 15, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

2.4 years

First QC Date

September 19, 2017

Results QC Date

August 21, 2023

Last Update Submit

September 12, 2023

Conditions

Tattoo Removal

Outcome Measures

Primary Outcomes (1)

  • Degree of Tattoo Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator

    Degree of tattoo clearing using the GAIS (Global Assessment of Improvement Scale) 3 = Very Significant Improvement, 2 = Significant Improvement, 1 = Moderate Improvement, or 0 = Mild or No Improvement Higher scores indicate better outcomes

    6 weeks post-final treatment

Study Arms (1)

arm-1

OTHER

Cutera enLighten laser treatments that allows the user to choose a wavelength between 640nm to 800nm.

Device: Cutera enLighten laser

Interventions

Cutera enLighten laserDEVICE

Subjects will receive laser treatments.

arm-1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female or Male, 18 to 65 years of age (inclusive).
  • Fitzpatrick Skin Type I - VI (Appendix 3).
  • 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.

You may not qualify if:

  • 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.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cutera Research Center

Brisbane, California, 94005, United States

Location

Skin Care Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Results Point of Contact

Title
Margot Doucette
Organization
Cutera
mdoucette@cutera.com
415-657-5518

Study Officials

  • Stephen Ronan, M.D.

    Cutera Research Center

    PRINCIPAL INVESTIGATOR

  • Jeffrey Dover, M.D.

    Skin Care Physicians

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 25, 2017

Study Start

July 8, 2015

Primary Completion

November 29, 2017

Study Completion

November 29, 2017

Last Updated

September 15, 2023

Results First Posted

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)