NCT02910505

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2017

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

September 16, 2016

Results QC Date

August 24, 2023

Last Update Submit

September 18, 2023

Conditions

Tattoo Removal

Outcome Measures

Primary Outcomes (1)

  • Tattoo Clearing as Rated by Investigator

    Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). 4= Very Significant or Complete Clearing 3= Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing Higher scores indicate better outcomes

    6 weeks post-final treatment

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with investigational Cutera enlighten laser for tattoo removal

Device: enLighten Laser

Interventions

enLighten LaserDEVICE

Laser for tattoo removal

Treatment

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.
  • 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 (1)

Connecticut Skin Institute

Stamford, Connecticut, 06905, United States

Location

Results Point of Contact

Title
Margot Doucette
Organization
Cutera
mdoucette@cutera.com
415-656-9612

Study Officials

  • Omar Ibrahimi, MD

    Connecticut Skin Institute

    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 16, 2016

First Posted

September 22, 2016

Study Start

October 1, 2016

Primary Completion

June 28, 2017

Study Completion

July 28, 2017

Last Updated

September 21, 2023

Results First Posted

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)