Tattoo RemovalNCT01973166
Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo Removal
A study testing Picosecond Q-switched Laser Treatment and Nanosecond Q-switched Laser Treatment in people with Tattoo Removal, run by Cutera Inc. at 1 site in United States.
Trial 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. 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?
- Picosecond Q-switched Laser Treatment and Nanosecond Q-switched Laser Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jul 2014
- 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
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Split-tattoo Study Comparing Safety and Efficacy of Picosecond and Nanosecond Q-switched Nd:YAG Lasers for Tattoo Removal
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.
Read the detailed description
This is a two center study to evaluate the Cutera RF system. Subjects will be treated on the abdomen and / or flanks areas and / or saddle bag (upper lateral thigh, lateral hip and lower buttocks).
The objective of this study is to evaluate the thermal and histological changes observed in the subcutaneous tissue following RF exposure.
- Conditions
- Tattoo Removal
- Being tested
- Picosecond Q-switched Laser Treatment, Nanosecond Q-switched Laser Treatment
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picosecond Q-switched Laser TreatmentDevice
Nanosecond Q-switched Laser TreatmentDevice
| Study group | Role | What they receive |
|---|---|---|
| Picosecond Q-switched Laser Treatment | Experimental | Picosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser Receives: Device: Picosecond Q-switched Laser Treatment |
| Nanosecond Q-switched Laser Treatment | Active comparator | Nanosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser Receives: Device: Nanosecond Q-switched Laser Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tattoo Clearing at 6 Weeks Post-final Laser Treatment for Each Treatment Arm as Assessed by Blinded Reviewers.
Physician's Global Assessment Scale: 0 (min) - 4 (max) Higher scores represent better tattoo clearing 4 = Very Significant Clearing (> 75%) 3 = Significant Clearing (51 - 75%) 2 = Moderate Clearing (26 - 50%)
1 = Mild Clearing (5 - 25%) 0 = No Change (< 5%)
Measured: 6-weeks post-final treatment
Secondary outcomes (1)
Comparison of Subject Discomfort (Pain) Between Treatment and Active Control Treatment Arms During Treatment
Numeric Pain Rating Scale (Min=0; Max=10) Higher scores mean worse outcome
Measured: During treatment, approximately 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2014
- Study completionJul 2014
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Apfelberg, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973166
- Sponsor's protocol ID
- C-13-TPS04
- Status last verified
- Jan 2023
- First submitted
- 25 Oct 2013
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Split-tattoo Study Comparing Safety and Efficacy of Picosecond and Nanosecond Q-switched Nd:YAG Lasers for Tattoo Removal
- ClinicalTrials.gov ID
- NCT01973166
- Acronym / sponsor ID
- C-13-TPS04
- Conditions
- Tattoo Removal
- Keywords
- Tattoo Removal, Q-switched laser, Nd:YAG laser, Nanosecond laser, Picosecond laser, Laser therapy, Tattoo, pulsed-laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a two center study to evaluate the Cutera RF system. Subjects will be treated on the abdomen and / or flanks areas and / or saddle bag (upper lateral thigh, lateral hip and lower buttocks).
The objective of this study is to evaluate the thermal and histological changes observed in the subcutaneous tissue following RF exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Picosecond Q-switched Laser Treatment | Experimental | Device: Picosecond Q-switched Laser TreatmentPicosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser |
| Nanosecond Q-switched Laser Treatment | Active comparator | Device: Nanosecond Q-switched Laser TreatmentNanosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (27 listed)
- 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
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 |
|---|---|---|
| Picosecond Q-switched Laser Treatment | Device | Picosecond Q-switched Laser Treatment |
| Nanosecond Q-switched Laser Treatment | Device | Nanosecond Q-switched Laser Treatment |
Primary outcome
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
Physician's Global Assessment Scale: 0 (min) - 4 (max) Higher scores represent better tattoo clearing 4 = Very Significant Clearing (> 75%) 3 = Significant Clearing (51 - 75%) 2 = Moderate Clearing (26 - 50%) 1 = Mild Clearing (5 - 25%) 0 = No Change (< 5%)
1 secondary outcome
Comparison of Subject Discomfort (Pain) Between Treatment and Active Control Treatment Arms During Treatment
Time frame: During treatment, approximately 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Apfelberg principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Picosecond Q-switched Laser Treatment and Nanosecond Q-switched Laser Treatment in people with Tattoo Removal, run by Cutera Inc. at 1 site 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 12 inclusion and 27 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 21 Feb 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 at 6 Weeks Post-final Laser Treatment for Each Treatment Arm as Assessed by Blinded Reviewers. (time frame: 6-weeks post-final treatment). 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 21 Feb 2023.