Tattoo; PigmentationPhase 1/2PicoSNCT03386760
Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos
A Phase 1/2 study testing Laser Utilisation PicoSecond and Laser Utilisation Nano-second in people with Tattoo; Pigmentation, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The investigators developed an ultra-speed picosecond laser (20ps) with a 20gHz repetition rate that provide very promising results in vitro and in ex vivo skin to remove skin tattoos. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tattoo; Pigmentation
- What is being tested?
- Laser Utilisation PicoSecond and Laser Utilisation Nano-second
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2018to 8 Jul 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Black tattoos with surface between 10 and 100 cm²
- Skin type I to VI
Who cannot join
- Childbearing age women
- Active dermatosis located on the tattoo
- Personal history of hypertrophic scars or keloids
- Pigmentary or vascular lesions located on the tattoo
- Subject taking oral steroid or retinoid or have any risk of delayed healing problems
- Acquired or hereditary conditions that could leead to a delayed healing
- Allergy to xylocaine, prilocaine or lidocaine
Trial locations and contacts
1 site in 1 country.
About this study
The investigators developed an ultra-speed picosecond laser (20ps) with a 20gHz repetition rate that provide very promising results in vitro and in ex vivo skin to remove skin tattoos.
The aim of this study is to evaluate the efficacy and tolerance of a new ultra-speed picosecond laser and to compare it to a nanosecond laser for treating black tattoos.
Read more
In a first phase of the study 10 patients with black tattoos will be treated with increasing fluencies of the picosecond laser to the optimal parameters in terms of efficacy and tolerance.
In a second phase, 10 additional subjects with black tattoos will be treated after central randomization on half of the tattoo with the picosecond laser (with the parameters determined in the first phase) and the other half treated with a nanosecond laser.
- Conditions
- Tattoo; Pigmentation
- Being tested
- Laser Utilisation PicoSecond, Laser Utilisation Nano-second
- Keywords
- tattoo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Utilisation PicoSecondDevice
Laser utilisation for tattoo depigmentation
1 session every month for a total of 3 sessions
Laser Utilisation Nano-secondDevice
Laser utilisation for tattoo depigmentation
1 session every month for a total of 3 sessions
| Study group | Role | What they receive |
|---|---|---|
| A- Ultra-Speed Picosecond laser | Experimental | Utilisation of Ultra-speed Picosecond laser for tattoo depigmentation Receives: Device: Laser Utilisation PicoSecond |
| B- Nanosecond laser | Active comparator | Utilisation of Nanosecond laser for tattoo depigmentation Receives: Device: Laser Utilisation Nano-second |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of decrease of tattoos 2 months after the third session as compared to baseline on standardized pictures
Measured: 2 month after the end of laser utilisation
Secondary outcomes (4)
Evaluation of Pain with EVA test
Measured: 2 months after one session of laser utilisation
Evaluation of tolerance
correlation between EVA test and dermatological clinical signs
Measured: 2 months after one session of laser utilisation
satisfaction evaluation of depigmanetation tattoo
satisfaction tests
Measured: 2 months after one session of laser utilisation
Skin biopsies
Measured: immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start15 Jan 2018
- Primary completion8 Jul 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tattoo; PigmentationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386760
- Sponsor's protocol ID
- 17-PP-07
- Acronym
- PicoS
- Status last verified
- Jul 2024
- First submitted
- 18 Dec 2017
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos
- ClinicalTrials.gov ID
- NCT03386760
- Acronym / sponsor ID
- PicoS / 17-PP-07
- Conditions
- Tattoo; Pigmentation
- Keywords
- tattoo
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators developed an ultra-speed picosecond laser (20ps) with a 20gHz repetition rate that provide very promising results in vitro and in ex vivo skin to remove skin tattoos.
The aim of this study is to evaluate the efficacy and tolerance of a new ultra-speed picosecond laser and to compare it to a nanosecond laser for treating black tattoos.
In a first phase of the study 10 patients with black tattoos will be treated with increasing fluencies of the picosecond laser to the optimal parameters in terms of efficacy and tolerance.
In a second phase, 10 additional subjects with black tattoos will be treated after central randomization on half of the tattoo with the picosecond laser (with the parameters determined in the first phase) and the other half treated with a nanosecond laser.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A- Ultra-Speed Picosecond laser | Experimental | Device: Laser Utilisation PicoSecondUtilisation of Ultra-speed Picosecond laser for tattoo depigmentation |
| B- Nanosecond laser | Active comparator | Device: Laser Utilisation Nano-secondUtilisation of Nanosecond laser for tattoo depigmentation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Black tattoos with surface between 10 and 100 cm²
- Skin type I to VI
Key exclusion criteria (7 listed)
- Childbearing age women
- Active dermatosis located on the tattoo
- Personal history of hypertrophic scars or keloids
- Pigmentary or vascular lesions located on the tattoo
- Subject taking oral steroid or retinoid or have any risk of delayed healing problems
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 |
|---|---|---|
| Laser Utilisation PicoSecondLaser utilisation for tattoo depigmentation 1 session every month for a total of 3 sessions | Device | A- Ultra-Speed Picosecond laser |
| Laser Utilisation Nano-secondLaser utilisation for tattoo depigmentation 1 session every month for a total of 3 sessions | Device | B- Nanosecond laser |
Primary outcome
Percentage of decrease of tattoos 2 months after the third session as compared to baseline on standardized pictures
Time frame: 2 month after the end of laser utilisation
4 secondary outcomes
Evaluation of Pain with EVA test
Time frame: 2 months after one session of laser utilisation
Evaluation of tolerance
Time frame: 2 months after one session of laser utilisation
satisfaction evaluation of depigmanetation tattoo
Time frame: 2 months after one session of laser utilisation
Skin biopsies
Time frame: immediately after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Laser Utilisation PicoSecond and Laser Utilisation Nano-second in people with Tattoo; Pigmentation, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 2 inclusion and 7 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 22 Jul 2024. 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 France. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of decrease of tattoos 2 months after the third session as compared to baseline on standardized pictures (time frame: 2 month after the end of laser utilisation). 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 22 Jul 2024.