Tattoo RemovalNCT02935660
Multi-Wavelength Laser Tattoo Removal Pivotal Study
A study testing enLighten Laser in people with Tattoo Removal, run by Cutera Inc. at 2 sites in United States.
Trial summary
Multi-center study to evaluate the safety and efficacy of an investigational version of the Cutera enlighten laser that offers multiple wavelengths for tattoo removal Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tattoo Removal
- What is being tested?
- enLighten Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or Male, 18 to 65 years of age (inclusive).
- Fitzpatrick Skin Type I - VI.
- Target tattoo contains single or multi-color ink, and must include blue and/or green ink.
- Target tattoos must be older than 1 year.
- Target treatment area not to exceed 12 square inches.
- Subject must be able to read, understand and sign the Informed Consent Form.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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 per investigator's discretion.
- 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, as applicable, within 6 months of study participation.
- Anytime in life, having 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cutera Research Clinic
Brisbane, California, 94005
Skin Care Physicians
Chestnut Hill, Massachusetts, 02467
About this study
Official title: A Prospective, Multi-Center Pivotal Clinical Evaluation of a Novel Multi-Wavelength Laser for Tattoo Removal
Multi-center study to evaluate the safety and efficacy of an investigational version of the Cutera enlighten laser that offers multiple wavelengths for tattoo removal
Read the detailed description
A multi-center prospective, open-label, uncontrolled pivotal study to evaluate the safety and efficacy of an investigational version of the Cutera enlighten laser that offers multiple wavelengths for tattoo removal.
- Conditions
- Tattoo Removal
- Being tested
- enLighten Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enLighten LaserDevice
Laser tattoo removal treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with investigational Cutera enlighten laser for tattoo removal Receives: Device: enLighten Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tattoo Clearing as Rated by Blinded Evaluator
Percentage of subjects with tattoo ink clearing of at least 50% or more at 6 weeks post-final treatment
Measured: 6 weeks post-final treatment, approximately 7 months after study start
Secondary outcomes (3)
Degree of Overall Tattoo Ink Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator (Physician's Global Assessment of Improvement).
Physician's Global Assessment of Improvement (min=0; max=4) Higher scores mean better outcomes
Measured: 6 weeks post-final treatment, approximately 7 months after study start
Subject Satisfaction Levels at 6 Weeks Post-final Treatment
Measured: 6 weeks post-final treatment, approximately 7 months after study start
Subject Pain During Treatment
Numeric Pain Rating Scale (Min=0; Max=10) Higher scores indicate worse outcomes Pain values from all treatment visits and subjects were combined and averaged.
Measured: Reported by subject at the end of each treatment visit, up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tattoo RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935660
- Sponsor's protocol ID
- C-16-EN13
- Status last verified
- Sep 2023
- First submitted
- 14 Oct 2016
- Last updated
- 26 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Pivotal Clinical Evaluation of a Novel Multi-Wavelength Laser for Tattoo Removal
- ClinicalTrials.gov ID
- NCT02935660
- Acronym / sponsor ID
- C-16-EN13
- Conditions
- Tattoo Removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Posted 26 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-center study to evaluate the safety and efficacy of an investigational version of the Cutera enlighten laser that offers multiple wavelengths for tattoo removal
Detailed description
A multi-center prospective, open-label, uncontrolled pivotal study to evaluate the safety and efficacy of an investigational version of the Cutera enlighten laser that offers multiple wavelengths for tattoo removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: enLighten LaserTreatment with investigational Cutera enlighten laser for tattoo removal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female or Male, 18 to 65 years of age (inclusive).
- Fitzpatrick Skin Type I - VI.
- Target tattoo contains single or multi-color ink, and must include blue and/or green ink.
- Target tattoos must be older than 1 year.
- Target treatment area not to exceed 12 square inches.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enLighten LaserLaser tattoo removal treatment | Device | Treatment |
Primary outcome
Tattoo Clearing as Rated by Blinded Evaluator
Time frame: 6 weeks post-final treatment, approximately 7 months after study start
Percentage of subjects with tattoo ink clearing of at least 50% or more at 6 weeks post-final treatment
3 secondary outcomes
Degree of Overall Tattoo Ink Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator (Physician's Global Assessment of Improvement).
Time frame: 6 weeks post-final treatment, approximately 7 months after study start
Subject Satisfaction Levels at 6 Weeks Post-final Treatment
Time frame: 6 weeks post-final treatment, approximately 7 months after study start
Subject Pain During Treatment
Time frame: Reported by subject at the end of each treatment visit, up to 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Tattoo Removal
Not yet recruiting
Evaluation of Automated Laser-Assisted Tattoo Removal: a Prospective Feasibility Clinical Study
Persons Seeking Tattoo Removal
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enLighten Laser in people with Tattoo Removal, run by Cutera Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tattoo Clearing as Rated by Blinded Evaluator (time frame: 6 weeks post-final treatment, approximately 7 months after study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.