Tattoo; PigmentationNCT03415685
Lutronic PicoPlus Exploratory Clinical Trial
A study testing PicoPlus laser system in people with Tattoo; Pigmentation and Melasma, run by CynosureLutronic at 4 sites in United States.
Trial summary
This study will evaluate the use of the Lutronic PicoPlus for treatment of dermatological conditions such as unwanted tattoos and benign pigmented lesions. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tattoo; Pigmentation, Melasma, Benign Pigmented Lesion
- What is being tested?
- PicoPlus laser system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Oct 2017to 3 Oct 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or Female
- Adults between age 18 and 60 years old
- Group A: Fitzpatrick skin type I - VI for unwanted tattoos and Group B: Fitzpatrick Skin Types I - IV for benign pigmented lesions and other conditions
- Unwanted tattoo that contains single or multi-color ink, and
- 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
- Ability to read, understand, and sign the Informed Consent Form
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- Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated
- Willing and able to comply with all study participation requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
Who cannot join
- If receiving treatment for unwanted tattoo: double tattoos (tattoo over tattoo), history of allergic reactions to pigments following tattooing, local anesthetics or topical antibiotics
- If receiving treatment for benign pigmented lesions including melasma: history of use of a lightening medication (hydroquinone, tranexamic acid), isotretinoid (or retinoid), or light-sensitive medication in the last 6 months
- Known cardiovascular disease or cardiac surgery that in the opinion of the investigator would interfere with study treatments
- Previous interventions or treatment with another device in the target area within 6 months of enrollment or during the study
- Pregnant or lactating or planning pregnancy before end of study
- Presence of an active systemic, local skin disease, medication or condition that may affect wound healing or interfere with participation or treatment to the active area.
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- Active or recurrent cancer of current chemotherapy or radiation therapy
- History of seizure disorders due to light
- History of vitiligo, eczema, or psoriasis
- History of connective tissue disease, such as systemic lupus erythematosus or scleroderma
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation
- 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 keloid scarring, hypertrophic scarring or of abnormal wound healing.
- History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- History of seizure disorders due to light.
- Suffering from coagulation disorders or taking prescription anticoagulation medications
- History of keloid scarring, hypertrophic scarring or of abnormal wound healing Any use of medication that is known to increase sensitivity to light according to Investigator's discretion
- Excessive or recent significant tan in areas to be treated or unable/unlikely to refrain from tanning during the study
- Current smoker or history of smoking within 3 months of study participation
- Systemic use of corticosteroid or isotretinoin within 6 months of study participation
- Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus
- Any physical or mental condition including alcohol or drug abuse that in the opinion of the investigator could interfere with subject's suitability for inclusion in study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dermatology, Laser, and Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Metro Dermatology
Elmhurst, New York, 11373
Laser and Skin Surgery Center of New York
New York, New York, 10016
Zena Medical
Newport Beach, California, 92660
About this study
Official title: Evaluation of the Lutronic PicoPlus for the Treatment of Dematological Conditions Such as Unwanted Tattoos and Benign Pigmented Lesions
This study will evaluate the use of the Lutronic PicoPlus for treatment of dermatological conditions such as unwanted tattoos and benign pigmented lesions.
Read the detailed description
This pilot clinical trial will evaluate the capability of the Lutronic PicoPlus technology to remove unwanted tattoos and benign pigmented lesions. This trial is designed as a multi-center exploratory, open-label clinical trial comparing each subject's condition before and after treatment. Subjects meeting all entrance criteria will be assigned to Group A for treatment of unwanted tattoos and Group B for treatment of unwanted benign pigmented lesions, melasma, or other skin conditions such as skin rejuvenation. Subjects in each treatment group will receive a series of treatments, e.g., 2-5, and will be asked to complete 1 and 3 month follow-up visit(s) following each treatment to assess treatment efficacy and safety. At investigators' discretion, additional follow-up visits, e.g., at 6 months following treatment, may take place to observe the time course of reactions after treatment and/or assess efficacy. Outcome measures include clinician grading and subject satisfaction post-treatment. Pre-treatment study photos will be obtained at baseline; post-treatment study photos will be obtained at each post-treatment follow-up visit.
- Conditions
- Tattoo; Pigmentation, Melasma, Benign Pigmented Lesion
- Being tested
- PicoPlus laser system
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicoPlus laser systemDevice
Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.
| Study group | Role | What they receive |
|---|---|---|
| Group A: PicoPlus for unwanted tattoos. | Active comparator | Subjects receiving PicoPlus laser system treatment for unwanted tattoos. Receives: Device: PicoPlus laser system |
| Group B: PicoPlus for other dermatological conditions | Active comparator | Subjects receiving PicoPlus laser system treatment for unwanted benign pigmented lesions, melasma or other dermatological conditions such as skin rejuvenation. Receives: Device: PicoPlus laser system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment of Improvement
Overall aesthetic improvement based on completion of the Physician's Global Assessment of Improvement Scale. Physician evaluators will review study photos post-final treatment, and rate the degree of tattoo clearing or reduction in benign pigmentation observed in the subject's treated area using the following definitions:
3 = Very significant or complete clearing (75-100%)
2 = Significant clearing (50-74%)
1 = Moderate clearing (25-49%)
0 = Mild or no clearing (0-24%)
Measured: Up to 6 Months following final study treatment
Secondary outcomes (2)
Subject's Global Assessment of Improvement
Overall aesthetic improvement based on completion of the Subject's Global Assessment of Improvement Scale. Subjects will be asked review study photos post-final treatment, and rate the degree of tattoo clearing or reduction in benign pigmentation observed in the subject's treated area using the following definitions:
3 = Very significant or complete clearing (75-100%)
2 = Significant clearing (50-74%)
1 = Moderate clearing (25-49%)
0 = Mild or no clearing (0-24%)
Measured: 1 month, 3 Months, 6 Months (Group A Only) post final treatment
Subject Satisfaction
Following the final study treatment, subjects will be asked to rate their level of satisfaction with the laser treatment outcome and the overall laser treatment procedure, using the Subject Satisfaction Assessment Scale and the following definitions:
2 = Extremely Satisfied
1 = Satisfied
0 = Neutral
(-1) = Unsatisfied
(-2) = Extremely Unsatisfied
Measured: 1 month, 3 Months, 6 Months (Group A Only) post final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start12 Oct 2017
- Primary completion6 Sep 2018
- Study completion3 Oct 2018
Why it stopped: Study stopped due to pivot in company clinical strategy.
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; PigmentationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be assigned to one of two treatments group depending on the dermatologic condition to be treated.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- CynosureLutronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kari Larson, MBA, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415685
- Sponsor's protocol ID
- L16004
- Status last verified
- Nov 2023
- First submitted
- 8 Jan 2018
- Last updated
- 20 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Lutronic PicoPlus for the Treatment of Dematological Conditions Such as Unwanted Tattoos and Benign Pigmented Lesions
- ClinicalTrials.gov ID
- NCT03415685
- Acronym / sponsor ID
- L16004
- Conditions
- Tattoo; Pigmentation, Melasma, Benign Pigmented Lesion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to pivot in company clinical strategy.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- CynosureLutronicIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the use of the Lutronic PicoPlus for treatment of dermatological conditions such as unwanted tattoos and benign pigmented lesions.
Detailed description
This pilot clinical trial will evaluate the capability of the Lutronic PicoPlus technology to remove unwanted tattoos and benign pigmented lesions. This trial is designed as a multi-center exploratory, open-label clinical trial comparing each subject's condition before and after treatment. Subjects meeting all entrance criteria will be assigned to Group A for treatment of unwanted tattoos and Group B for treatment of unwanted benign pigmented lesions, melasma, or other skin conditions such as skin rejuvenation. Subjects in each treatment group will receive a series of treatments, e.g., 2-5, and will be asked to complete 1 and 3 month follow-up visit(s) following each treatment to assess treatment efficacy and safety. At investigators' discretion, additional follow-up visits, e.g., at 6 months following treatment, may take place to observe the time course of reactions after treatment and/or assess efficacy. Outcome measures include clinician grading and subject satisfaction post-treatment. Pre-treatment study photos will be obtained at baseline; post-treatment study photos will be obtained at each post-treatment follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be assigned to one of two treatments group depending on the dermatologic condition to be treated.
| Arm | Type | Receives |
|---|---|---|
| Group A: PicoPlus for unwanted tattoos. | Active comparator | Device: PicoPlus laser systemSubjects receiving PicoPlus laser system treatment for unwanted tattoos. |
| Group B: PicoPlus for other dermatological conditions | Active comparator | Device: PicoPlus laser systemSubjects receiving PicoPlus laser system treatment for unwanted benign pigmented lesions, melasma or other dermatological conditions such as skin rejuvenation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or Female
- Adults between age 18 and 60 years old
- Group A: Fitzpatrick skin type I - VI for unwanted tattoos and Group B: Fitzpatrick Skin Types I - IV for benign pigmented lesions and other conditions
- Unwanted tattoo that contains single or multi-color ink, and
- Ability to read, understand, and sign the Informed Consent Form
Key exclusion criteria (22 listed)
- If receiving treatment for unwanted tattoo: double tattoos (tattoo over tattoo), history of allergic reactions to pigments following tattooing, local anesthetics or topical antibiotics
- If receiving treatment for benign pigmented lesions including melasma: history of use of a lightening medication (hydroquinone, tranexamic acid), isotretinoid (or retinoid), or light-sensitive medication in the last 6 months
- Known cardiovascular disease or cardiac surgery that in the opinion of the investigator would interfere with study treatments
- Previous interventions or treatment with another device in the target area within 6 months of enrollment or during the study
- Pregnant or lactating or planning pregnancy before end of study
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 |
|---|---|---|
| PicoPlus laser systemLaser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis. | Device | Group A: PicoPlus for unwanted tattoos., Group B: PicoPlus for other dermatological conditions |
Primary outcome
Investigator's Global Assessment of Improvement
Time frame: Up to 6 Months following final study treatment
Overall aesthetic improvement based on completion of the Physician's Global Assessment of Improvement Scale. Physician evaluators will review study photos post-final treatment, and rate the degree of tattoo clearing or reduction in benign pigmentation observed in the subject's treated area using the following definitions: 3 = Very significant or complete clearing (75-100%) 2 = Significant clearing (50-74%) 1 = Moderate clearing (25-49%) 0 = Mild or no clearing (0-24%)
2 secondary outcomes
Subject's Global Assessment of Improvement
Time frame: 1 month, 3 Months, 6 Months (Group A Only) post final treatment
Subject Satisfaction
Time frame: 1 month, 3 Months, 6 Months (Group A Only) post final treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Kari Larson, MBA study director
Sponsor GmbH
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PicoPlus laser system in people with Tattoo; Pigmentation and Melasma, run by CynosureLutronic at 4 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 9 inclusion and 22 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: stopped early, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 20 Dec 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?
Investigator's Global Assessment of Improvement (time frame: Up to 6 Months following final study 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 20 Dec 2023.